510(k) · Cleared
ClearedRepicci II Metal Back Inlay Unicompartmental Tibial Bearing Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Oct 19, 2006 as substantially equivalent to K971938 (Biomet, Inc., 1997) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 19, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971938 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- This deviceK061681 Repicci II Metal Back Inlay Unicompartmental Tibial Bearing ComponentBiomet Manufacturing Corp · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971938 | Repicci II Unicondylar Knee | Biomet, Inc. | 1997 | 1 |
| 0 (this device) | K061681 | Repicci II Metal Back Inlay Unicompartmental Tibial Bearing Component | Biomet Manufacturing Corp | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (2)
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 |
|---|---|---|---|
| * | K971938 | Repicci II Unicondylar KneeSummary page 1…ned cemented prosthesis (21 CFR 888.3530) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Repiocd II® Unicondylar Knee (K971938) 2. RepicdcII® Unicondylar Knee All Poly Tibial Components (K980665) Device Description: The Repicci II® Metal Back Inlay Unicom… | 1997 |
| * | K980665 | Repicci II Unicondylar Knee All Poly Tibial ComponentsSummary page 1…egally Marketed Devices To Which Substantial Equivalence Is Claimed: 1. Repiocd II® Unicondylar Knee (K971938) 2. RepicdcII® Unicondylar Knee All Poly Tibial Components (K980665) Device Description: The Repicci II® Metal Back Inlay Unicompartmental Tibial Component is a tibial component comprised of ultra… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 2 of the 2 ancestors have a recall of any class.
- 13 other devices also cite its predicate K971938.
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.
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?
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. The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061681: Repicci II Metal Back Inlay Unicompartmental Tibial Bearing Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061681
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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