510(k) · Cleared
ClearedRepicci II Unicondylar Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Orthopedics, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Feb 8, 2002 as substantially equivalent to K971938 (Biomet, Inc., 1997) after a 14-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Feb 8, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971938 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK971938 Repicci II Unicondylar KneeBiomet, Inc. · 1997 · Recalled
- This deviceK020264 Repicci II Unicondylar Knee SystemBiomet Orthopedics, Inc. · 2002
- Descendant · cites it directly · 2 of its ownK063515 Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci…Biomet Manufacturing, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK203341 ACS LD Uni FB Knee SystemImplantcast GmbH · 2021
- Descendant · 3 generations on · 0 of its ownK260037 implantcast Packaging System UpdateImplantcast GmbH · 2026
- Descendant · cites it directly · 0 of its ownK072704 Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K063515Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeBiomet Manufacturing, Inc. · 2007 · cites it directly2descendants
- K203341ACS LD Uni FB Knee SystemImplantcast GmbH · 2021 · 2 generations on1descendant
- K260037implantcast Packaging System UpdateImplantcast GmbH · 2026 · 3 generations on0descendants
- K072704Unicompartmental KneeValpo Orthopedic Technology, Inc. · 2008 · cites it directly0descendants
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) | K020264 | Repicci II Unicondylar Knee System | Biomet Orthopedics, Inc. | 2002 | — |
| +1 | K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II… | Biomet Manufacturing, Inc. | 2007 | — |
| +2 | K203341 | ACS LD Uni FB Knee System | Implantcast GmbH | 2021 | — |
| +3 | K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026 | — |
| +1 | K072704 | Unicompartmental Knee | Valpo Orthopedic Technology, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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? (1)
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…emented prosthesis (CFR 888.3560). Device Classification: Class II Legally Marketed Device to which Substantially Equivalence is Claimed: Repicci II™ Unicondylar Knee (K971938) Device Description: The Repicci II™ Unicondylar Porous Knee is the same as the predicate, the Repicci [I™ Unicondylar Knee (K97… | 1997 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
The indications for use for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis. rheumatoid arthritis. traumatic arthritis where one or more compartments are involved: the correction of varus. valgus. or posttraumatic deformity: and the correction or revision of unsuccessful osteotomy. arthrodesis. or failure of previous joint replacement procedure.
This device is for use with bone cement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020264: Repicci II Unicondylar Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020264
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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