FDA product code · Orthopedic
HTYPin, Fixation, Smooth
Product code HTY covers Pin, Fixation, Smooth, a Class II device regulated under 21 CFR 888.3040. FDA has cleared 204 devices in this code, 2 of them in the last 12 months. Median review time across the 204 most recent decisions is 85 days. openFDA lists 31 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3040
- Review panel
- Orthopedic
- Clearances
- 204
What is happening in HTY right now?
HTY (Pin, Fixation, Smooth) has two findings, most consequential first. 1 first-time filer in the last 12 months, TOETAL SOLUTIONS, INC (K253325). The code is crowded, scoring 70 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months (HTY:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253325 |
| Crowding | Context | HTY: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 HTY?
FDA has cleared 204 devices under product code HTY since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253325 | ZipToe Hammertoe Fusion System | Toetal Solutions | |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | |
| K250315 | RONAVIS FX (FX-001) | AIRS, Inc. | |
| K251362 | PediFlex Flexible Nail System | OrthoPediatrics Corp. | |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | |
| K231147 | Hammerdesis Interphalangeal Fusion System | Intelivation | |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. |
How long does FDA review take for HTY?
The median FDA review time for HTY is 85 days, measured across the 204 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 HTY?
openFDA lists 31 recall records against product code HTY. A recall record covers one firm's corrective action and may span many device lots.
Z-3171-2024Open, ClassifiedSmith & Nephew, Inc.
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Z-3172-2024Open, ClassifiedSmith & Nephew, Inc.
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Z-1468-2022Open, ClassifiedParagon 28, Inc.
Due to Titanium plasma coating not present implant.
Z-1011-2022Open, ClassifiedStryker Corporation
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
Z-0707-2022TerminatedBrasseler USA, Medical L.L.C.
One lot of product was distributed in unsealed packaging
Showing the 5 most recently initiated of 31. 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 HTY?
MAUDE holds 451 adverse-event reports naming product code HTY, 34 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 HTY unusual?
Every month with enough history behind it falls inside HTY's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 16 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 125 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 1 | 0–80 | Within expected (0–80) | |
| 2 | 0–66 | Within expected (0–66) | |
| 1 | 0–72 | Within expected (0–72) | |
| 3 | 0–72 | Within expected (0–72) | |
| 2 | 0–66 | Within expected (0–66) | |
| 4 | 0–68 | Within expected (0–68) | |
| 3 | 0–107 | Within expected (0–107) | |
| 5 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history |
28 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 HTY.
Who has entered HTY in the last year?
One company filed in HTY for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| TOETAL SOLUTIONS, INC | K253325 |
"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 HTY?
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 HTY?
Across the 204 most recent decisions, these applicants filed most often in HTY.
| Applicant | Recent clearances |
|---|---|
| Arthrex, Inc. | 13 |
| OSSIO , Ltd. | 6 |
| Biomet, Inc. | 5 |
| Synthes (Usa) | 5 |
| Bioretec, Ltd. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch HTY
Get an email the morning anything changes in HTY — 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.