FDA product code HRY: Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HRY is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3530 and reviewed by the Orthopedic panel. FDA has cleared 91 510(k) submissions under HRY, from 44 different applicants. The average 510(k) review took 106 days (median 84). 1 PMA application cites this product code. FDA has posted 68 recalls for HRY devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3530 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for HRY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 283 |
| 2020 | 1 | 118 |
Compare with all 510(k) review times · Search every HRY clearance
Top HRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Corp. | 11 | 1989-02-17 |
| Biomet, Inc. | 10 | 2004-11-01 |
| Wrightmedicaltechnologyinc | 6 | 2010-08-10 |
| Depuy, Inc. | 6 | 1995-09-26 |
| DePuy Orthopaedics, Inc. | 5 | 2007-08-17 |
39 more applicants have HRY clearances. See the full list in Caduvo.
Most recent HRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193549 | Depuy Ireland UC | SIGMA High Performance (HP) Partial Knee System | 2020-04-16 | 118 |
| K190633 | Nanoortho, LLC | NanoOrtho NanoKnee® System | 2019-12-20 | 283 |
| K152631 | Microport Orthopedics, Inc. | MPO Total Knee Systems MR Labeling | 2016-03-23 | 190 |
| K150410 | Mako Surgical Corporation | RESTORIS POROUS PARTIAL KNEE SYSTEM | 2015-03-20 | 30 |
| K133940 | Biomet UK, Ltd. | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) | 2014-03-28 | 95 |
Recalls for HRY devices
68 product recalls in 19 recall events; 4 initiated in the last five years and 5 still open. Most recent: 2024-05-03.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 3 |
| 2021 | 9 |
| 2022 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code HRY?
HRY is the FDA product code for prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3530 and reviewed by the Orthopedic panel.
What device class is HRY?
Class II, regulation 21 CFR 888.3530. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRY?
Across 91 cleared submissions the average was 106 days from receipt to decision (median 84).
Which companies have the most HRY clearances?
Howmedica Corp. (11); Biomet, Inc. (10); Wrightmedicaltechnologyinc (6); Depuy, Inc. (6); DePuy Orthopaedics, Inc. (5).
Have HRY devices been recalled?
Yes: 68 product recalls across 19 recall events; the most recent began 2024-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HRY
- Run a recall and safety report across every HRY manufacturer
- Watch product code HRY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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