FDA product code KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
KRR is the FDA product code for prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3540 and reviewed by the Orthopedic panel. FDA has cleared 27 510(k) submissions under KRR, 2 in the last five years, from 20 different applicants. The average 510(k) review took 108 days (median 89). FDA has posted 9 recalls for KRR devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3540 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for KRR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 30 |
| 2020 | 1 | 90 |
| 2021 | 1 | 36 |
| 2022 | 1 | 259 |
| 2023 | 1 | 67 |
Compare with all 510(k) review times · Search every KRR clearance
Top KRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Howmedica Osteonics Corp. | 4 | 2005-10-21 |
| Arthrosurface, Inc. | 3 | 2018-06-14 |
| Biomet, Inc. | 2 | 2015-01-30 |
| Mako Surgical Corp. | 2 | 2008-10-22 |
| Overture Resurfacing, Inc. | 1 | 2023-07-07 |
15 more applicants have KRR clearances. See the full list in Caduvo.
Most recent KRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231253 | Overture Resurfacing, Inc. | Overture Orthopaedics Patellofemoral System | 2023-07-07 | 67 |
| K221048 | Episurf Medical, Inc. | Episealer Patellofemoral System | 2022-12-23 | 259 |
| K211303 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Avon Patello-femoral Joint Prosthesis | 2021-06-04 | 36 |
| K200122 | Medacta International S.A. | MOTO PFJ System | 2020-04-20 | 90 |
| K181280 | Arthrosurface, Inc. | Patello-Femoral Wave (Kahuna) Arthroplasty System | 2018-06-14 | 30 |
Recalls for KRR devices
9 product recalls in 6 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2022-12-22.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2022 | 3 |
Frequently asked questions
What is FDA product code KRR?
KRR is the FDA product code for prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer. It is a Class II device, regulated under 21 CFR 888.3540 and reviewed by the Orthopedic panel.
What device class is KRR?
Class II, regulation 21 CFR 888.3540. Typical premarket route: 510(k).
How long does a 510(k) take for product code KRR?
Across 27 cleared submissions the average was 108 days from receipt to decision (median 89).
Which companies have the most KRR clearances?
Howmedica Osteonics Corp. (4); Arthrosurface, Inc. (3); Biomet, Inc. (2); Mako Surgical Corp. (2); Overture Resurfacing, Inc. (1).
Have KRR devices been recalled?
Yes: 9 product recalls across 6 recall events; the most recent began 2022-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KRR
- Run a recall and safety report across every KRR manufacturer
- Watch product code KRR 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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