FDA product code · Orthopedic
HRSPlate, Fixation, Bone
Product code HRS covers Plate, Fixation, Bone, a Class II device regulated under 21 CFR 888.3030. FDA has cleared 1,319 devices in this code, 59 of them in the last 12 months. Median review time across the 1,319 most recent decisions is 86 days. openFDA lists 286 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3030
- Review panel
- Orthopedic
- Clearances
- 1,319
What is happening in HRS right now?
HRS (Plate, Fixation, Bone) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2532-2026, Z-1592-2026, Z-1593-2026, Z-1594-2026, Z-1595-2026). 6 first-time filers in the last 12 months, including Chest Wall Innovations, Inc. and Actis Medical Pty., Ltd (K260411, K260090, K251732, K251050, K252997). The code is crowded, scoring 100 of 100 — 301 companies hold a clearance here and 59 arrived in the last 12 months (HRS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2532-2026, Z-1592-2026, Z-1593-2026, Z-1594-2026, Z-1595-2026 |
| New entrant | Worth knowing | K260411, K260090, K251732, K251050, K252997 |
| Crowding | Context | HRS: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 HRS?
FDA has cleared 1,319 devices under product code HRS since the 510(k) programme began in 1976, 59 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | |
| K261191 | Alians Elbow S | Newclip Technics | |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | |
| K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L | I.T.S. GmbH | |
| K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | |
| K260761 | APTUS Clavicle System 2.8 | Medartis AG | |
| K261002 | Pectus Blu System | Biomet Microfixation | |
| K261038 | Xpert PFP | Newclip Technics |
How long does FDA review take for HRS?
The median FDA review time for HRS is 86 days, measured across the 1,319 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 HRS?
openFDA lists 286 recall records against product code HRS. A recall record covers one firm's corrective action and may span many device lots.
Z-2532-2026Open, ClassifiedAcumed LLC
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
Z-1592-2026Open, ClassifiedI.T.S. GmbH
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1593-2026Open, ClassifiedI.T.S. GmbH
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1594-2026Open, ClassifiedI.T.S. GmbH
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Z-1595-2026Open, ClassifiedI.T.S. GmbH
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Showing the 5 most recently initiated of 286. 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 HRS?
MAUDE holds 6,192 adverse-event reports naming product code HRS, 1,502 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 HRS unusual?
Every month with enough history behind it falls inside HRS's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 103 | Insufficient history | No expected range — too little history | |
| 100 | Insufficient history | No expected range — too little history | |
| 212 | Insufficient history | No expected range — too little history | |
| 170 | Insufficient history | No expected range — too little history | |
| 294 | Insufficient history | No expected range — too little history | |
| 161 | Insufficient history | No expected range — too little history | |
| 132 | Insufficient history | No expected range — too little history | |
| 165 | Insufficient history | No expected range — too little history | |
| 121 | Insufficient history | No expected range — too little history | |
| 188 | Insufficient history | No expected range — too little history | |
| 138 | Insufficient history | No expected range — too little history | |
| 181 | Insufficient history | No expected range — too little history | |
| 223 | Insufficient history | No expected range — too little history | |
| 167 | Insufficient history | No expected range — too little history | |
| 145 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 120 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 119 | Insufficient history | No expected range — too little history | |
| 116 | Insufficient history | No expected range — too little history | |
| 185 | 46–203 | Within expected (46–203) | |
| 170 | 55–193 | Within expected (55–193) | |
| 136 | 73–236 | Within expected (73–236) | |
| 210 | 73–236 | Within expected (73–236) | |
| 133 | 89–230 | Within expected (89–230) | |
| 216 | 84–230 | Within expected (84–230) | |
| 230 | 141–407 | Within expected (141–407) | |
| 246 | 104–290 | Within expected (104–290) | |
| 129 | 127–321 | Within expected (127–321) | |
| 173 | 89–299 | Within expected (89–299) | |
| 209 | 74–263 | Within expected (74–263) | |
| 246 | 101–299 | Within expected (101–299) | |
| 117 | 145–352 | Below expected (145–352) | |
| 166 | 70–284 | Within expected (70–284) | |
| 256 | 73–305 | Within expected (73–305) |
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 HRS.
Who has entered HRS in the last year?
6 companies filed in HRS for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Chest Wall Innovations, Inc. | K260411 | |
| Actis Medical Pty., Ltd. | K260090 | |
| Met One Technologies, LLC | K251732 | |
| Gm Dos Reis Industria E Comercio | K251050 | |
| HyperFlex Medical Inc | K252997 | |
| Maxxos Medical GmbH | K251892 |
"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 HRS?
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 HRS?
Across the 1,319 most recent decisions, these applicants filed most often in HRS.
| Applicant | Recent clearances |
|---|---|
| Synthes (Usa) | 87 |
| Wrightmedicaltechnologyinc | 45 |
| Arthrex, Inc. | 39 |
| Smith & Nephew, Inc. | 34 |
| Medartis AG | 31 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in HRS 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 |
|---|---|---|
| Synthes USA | 95 | 3 |
| Smith & Nephew, Inc. | 37 | 2 |
| Medartis, Inc. | 32 | 2 |
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 HRS
Get an email the morning anything changes in HRS — 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.