510(k) · Cleared
ClearedTitanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Feb 2, 2007 as substantially equivalent to K041466 (Biomet Manufacturing Corp, 2004) and 3 other predicates after a 73-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Feb 2, 2007
- Review
- 73 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K971938 (1997). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- 1 generation backK020264 Repicci II Unicondylar Knee SystemBiomet Orthopedics, Inc. · 2002
- This deviceK063515 Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci…Biomet Manufacturing, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| −1 | K020264 | Repicci II Unicondylar Knee System | Biomet Orthopedics, Inc. | 2002 | — |
| 0 (this device) | K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II… | Biomet Manufacturing, Inc. | 2007 | — |
| +1 | K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021 | — |
| +2 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041466 | Titanium Femoral Knee Components (Maxim and Agc)Summary page 1…30) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Femoral Knee Components (Maxim® and AGC®) K041466 Biomet, Inc. Repicci II® Unicondylar Knee System K020264 Biomet, Inc. Titanium Femo… | 2004 |
| * | K020264 | Repicci II Unicondylar Knee SystemSummary page 1…Titanium Femoral Knee Components (Maxim® and AGC®) K041466 Biomet, Inc. Repicci II® Unicondylar Knee System K020264 Biomet, Inc. Titanium Femoral Component K(981996 Biomnet, Inc. Repicci II®… | 2002 |
| * | K981996 | Titanium Femoral ComponentSummary page 1…K041466 Biomet, Inc. Repicci II® Unicondylar Knee System K020264 Biomet, Inc. Titanium Femoral Component K(981996 Biomnet, Inc. Repicci II® Unicondylar Knee K(971938 Biomnet, Inc. Device Description: T… | 1999 |
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…K020264 Biomet, Inc. Titanium Femoral Component K(981996 Biomnet, Inc. Repicci II® Unicondylar Knee K(971938 Biomnet, Inc. Device Description: The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral un… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203341 | ACS LD Uni FB Knee System | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K203341 (Implantcast GmbH, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Titanium Repicci II® Unicondylar Femoral Knee Components and CoCr Repicci II® Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
These devices are single-use implants intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063515 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063515: Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar Knee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063515
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026