FDA product code · Orthopedic
HSBRod, Fixation, Intramedullary And Accessories
Product code HSB covers Rod, Fixation, Intramedullary And Accessories, a Class II device regulated under 21 CFR 888.3020. FDA has cleared 530 devices in this code, 22 of them in the last 12 months. Median review time across the 530 most recent decisions is 86 days. openFDA lists 690 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3020
- Review panel
- Orthopedic
- Clearances
- 530
What is happening in HSB right now?
HSB (Rod, Fixation, Intramedullary And Accessories) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2456-2026, Z-0967-2026, Z-0968-2026, Z-0969-2026, Z-0970-2026). 6 first-time filers in the last 12 months, including Suzhou and Science & Technology Development Corp. and Beijing Fule Science & Technology Development Co., Ltd (K253080, K253155, K253046, K252961, K253517). Clearances are running 38% slower — a median 119 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (HSB:review_time:12m). The code is crowded, scoring 97 of 100 — 159 companies hold a clearance here and 22 arrived in the last 12 months (HSB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2456-2026, Z-0967-2026, Z-0968-2026, Z-0969-2026, Z-0970-2026 |
| New entrant | Worth knowing | K253080, K253155, K253046, K252961, K253517 |
| Review time | Context | HSB:review_time:12m |
| Crowding | Context | HSB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in HSB?
FDA has cleared 530 devices under product code HSB since the 510(k) programme began in 1976, 22 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | Stryker GmbH | |
| K261651 | Precice Max System and Precice Ankle Salvage System | NuVasive Specialized Orthopedics | |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02) | Suzhou and Science & Technology Development Corp. | |
| K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | |
| K253046 | HERA Interlocking Intramedullary Nailing System | ZheJiang Decans Medical Devices Co., Ltd. | |
| K260146 | FITBONE® TRANSPORT AND LENGTHENING SYSTEM | Orthofix Srl | |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | |
| K261043 | AUTOBAHN Nailing System | Globus Medical, Inc. | |
| K252016 | Arthrex Humeral Nails | Arthrex, Inc. | |
| K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC |
How long does FDA review take for HSB?
The median FDA review time for HSB is 86 days, measured across the 530 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in HSB?
openFDA lists 690 recall records against product code HSB. A recall record covers one firm's corrective action and may span many device lots.
Z-2456-2026Open, ClassifiedSmith & Nephew, Inc.
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.
Z-0967-2026Open, ClassifiedZimmer, Inc.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0968-2026Open, ClassifiedZimmer, Inc.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0969-2026Open, ClassifiedZimmer, Inc.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0970-2026Open, ClassifiedZimmer, Inc.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Showing the 5 most recently initiated of 690. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for HSB?
MAUDE holds 7,924 adverse-event reports naming product code HSB, 1,777 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in HSB unusual?
One month sits above HSB's own expected range: 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 111 | Insufficient history | No expected range — too little history | |
| 199 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 219 | Insufficient history | No expected range — too little history | |
| 184 | Insufficient history | No expected range — too little history | |
| 208 | Insufficient history | No expected range — too little history | |
| 193 | Insufficient history | No expected range — too little history | |
| 200 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 193 | Insufficient history | No expected range — too little history | |
| 152 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 186 | Insufficient history | No expected range — too little history | |
| 235 | Insufficient history | No expected range — too little history | |
| 230 | Insufficient history | No expected range — too little history | |
| 655 | Insufficient history | No expected range — too little history | |
| 286 | Insufficient history | No expected range — too little history | |
| 208 | Insufficient history | No expected range — too little history | |
| 204 | Insufficient history | No expected range — too little history | |
| 153 | Insufficient history | No expected range — too little history | |
| 179 | Insufficient history | No expected range — too little history | |
| 252 | 0–427 | Within expected (0–427) | |
| 184 | 0–386 | Within expected (0–386) | |
| 170 | 0–427 | Within expected (0–427) | |
| 184 | 0–431 | Within expected (0–431) | |
| 194 | 0–400 | Within expected (0–400) | |
| 225 | 0–418 | Within expected (0–418) | |
| 351 | 0–679 | Within expected (0–679) | |
| 132 | 165–331 | Below expected (165–331) | |
| 186 | 126–320 | Within expected (126–320) | |
| 451 | 111–310 | Above expected (111–310) | |
| 188 | 107–401 | Within expected (107–401) | |
| 320 | 102–418 | Within expected (102–418) | |
| 167 | 139–506 | Within expected (139–506) | |
| 171 | 68–397 | Within expected (68–397) | |
| 193 | 49–420 | Within expected (49–420) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in HSB.
Who has entered HSB in the last year?
6 companies filed in HSB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Suzhou and Science & Technology Development Corp. | K253080 | |
| Beijing Fule Science & Technology Development Co., Ltd. | K253155 | |
| ZheJiang Decans Medical Devices Co., Ltd. | K253046 | |
| Fusion Orthopedics USA, LLC | K252961 | |
| Reselute, Inc. | K253517 | |
| Satori Orthopaedics, Inc. | K252025 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in HSB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in HSB?
Across the 530 most recent decisions, these applicants filed most often in HSB.
| Applicant | Recent clearances |
|---|---|
| Howmedica Osteonics Corp. | 38 |
| Howmedica Corp. | 23 |
| Synthes (Usa) | 22 |
| Zimmer, Inc. | 17 |
| Nuvasive Specialized Orthopedics, Inc. | 16 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
5 companies in HSB file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Howmedica Osteonics Corp. | 39 | 2 |
| Howmedica Corp. | 26 | 2 |
| Synthes USA | 23 | 2 |
| Zimmer, Inc. | 23 | 2 |
| NuVasive Specialized Orthopedics, Inc. | 18 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch HSB
Get an email the morning anything changes in HSB — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.