FDA product code · Orthopedic
HWCScrew, Fixation, Bone
Product code HWC covers Screw, Fixation, Bone, a Class II device regulated under 21 CFR 888.3040. FDA has cleared 1,061 devices in this code, 20 of them in the last 12 months. Median review time across the 1,061 most recent decisions is 88 days. openFDA lists 388 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3040
- Review panel
- Orthopedic
- Clearances
- 1,061
What is happening in HWC right now?
HWC (Screw, Fixation, Bone) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2361-2026, Z-1599-2026, Z-1606-2026, Z-1549-2026, Z-1550-2026). 5 first-time filers in the last 12 months, including Steps Ortho and Pace Surgical (K253108, K251555, K252758, K251382, K250867). The code is crowded, scoring 98 of 100 — 349 companies hold a clearance here and 20 arrived in the last 12 months (HWC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2361-2026, Z-1599-2026, Z-1606-2026, Z-1549-2026, Z-1550-2026 |
| New entrant | Worth knowing | K253108, K251555, K252758, K251382, K250867 |
| Crowding | Context | HWC: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 HWC?
FDA has cleared 1,061 devices under product code HWC since the 510(k) programme began in 1976, 20 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | |
| K261241 | TriMed Compression Screws | TriMed, Inc. | |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC |
How long does FDA review take for HWC?
The median FDA review time for HWC is 88 days, measured across the 1,061 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 HWC?
openFDA lists 388 recall records against product code HWC. A recall record covers one firm's corrective action and may span many device lots.
Z-2361-2026Open, ClassifiedMedartis, Inc.
The cannulation of the CCS screw is not centered.
Z-1599-2026Open, 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-1606-2026Open, 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-1549-2026Open, ClassifiedMedartis, Inc.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Z-1550-2026Open, ClassifiedMedartis, Inc.
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Showing the 5 most recently initiated of 388. 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 HWC?
MAUDE holds 9,954 adverse-event reports naming product code HWC, 1,843 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 HWC unusual?
One month sits above HWC's own expected range: 1 November 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 295 | Insufficient history | No expected range — too little history | |
| 267 | Insufficient history | No expected range — too little history | |
| 300 | Insufficient history | No expected range — too little history | |
| 275 | Insufficient history | No expected range — too little history | |
| 325 | Insufficient history | No expected range — too little history | |
| 308 | Insufficient history | No expected range — too little history | |
| 322 | Insufficient history | No expected range — too little history | |
| 355 | Insufficient history | No expected range — too little history | |
| 261 | Insufficient history | No expected range — too little history | |
| 367 | Insufficient history | No expected range — too little history | |
| 356 | Insufficient history | No expected range — too little history | |
| 247 | Insufficient history | No expected range — too little history | |
| 460 | Insufficient history | No expected range — too little history | |
| 490 | Insufficient history | No expected range — too little history | |
| 215 | Insufficient history | No expected range — too little history | |
| 194 | Insufficient history | No expected range — too little history | |
| 222 | Insufficient history | No expected range — too little history | |
| 335 | Insufficient history | No expected range — too little history | |
| 288 | Insufficient history | No expected range — too little history | |
| 189 | Insufficient history | No expected range — too little history | |
| 212 | Insufficient history | No expected range — too little history | |
| 249 | 14–437 | Within expected (14–437) | |
| 157 | 22–383 | Within expected (22–383) | |
| 174 | 8–412 | Within expected (8–412) | |
| 258 | 0–423 | Within expected (0–423) | |
| 280 | 54–365 | Within expected (54–365) | |
| 217 | 140–332 | Within expected (140–332) | |
| 274 | 210–512 | Within expected (210–512) | |
| 207 | 141–366 | Within expected (141–366) | |
| 223 | 133–375 | Within expected (133–375) | |
| 227 | 141–343 | Within expected (141–343) | |
| 332 | 124–302 | Above expected (124–302) | |
| 228 | 160–392 | Within expected (160–392) | |
| 170 | 169–437 | Within expected (169–437) | |
| 293 | 94–349 | Within expected (94–349) | |
| 237 | 125–407 | Within expected (125–407) |
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 HWC.
Who has entered HWC in the last year?
5 companies filed in HWC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Steps Ortho | K253108 | |
| Pace Surgical | K251555 | |
| Orthonovis, Inc. | K252758 | |
| Astra Orthomed, Inc. | K251382 | |
| Dunamis Medical, LLC | K250867 |
"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 HWC?
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 HWC?
Across the 1,061 most recent decisions, these applicants filed most often in HWC.
| Applicant | Recent clearances |
|---|---|
| Arthrex, Inc. | 46 |
| Wrightmedicaltechnologyinc | 31 |
| Synthes (Usa) | 30 |
| Smith & Nephew, Inc. | 27 |
| Biomet, Inc. | 24 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in HWC files 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 | 31 | 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 HWC
Get an email the morning anything changes in HWC — 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.