510(k) · Cleared
ClearedP.F.C. Uni-Compartmental Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Professionals, Inc. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Oct 10, 1996 after a 379-day review. The FDA summary names its predicate without a number. 60 later devices descend from it.
- Decided
- Oct 10, 1996
- Review
- 379 days
- Class
- Class II
- Product code
- HRY
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly.
- This deviceK954481 P.F.C. Uni-Compartmental Knee SystemJohnson & Johnson Professionals, Inc. · 1996
- Descendant · cites it directly · 47 of its ownK040268 Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 32 of its ownK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009
- Descendant · 3 generations on · 28 of its ownK111916 Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K040268Depuy Preservation Unicondylar TibiaDePuy Orthopaedics, Inc. · 2004 · cites it directly47descendants
- K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · 2 generations on32descendants
- K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · 2 generations on31descendants
- K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 3 generations on29descendants
- K111916Conformis Iuni Unicondylar Knee Replacement SystemConformis, Inc. · 2011 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954481 | P.F.C. Uni-Compartmental Knee System | Johnson & Johnson Professionals, Inc. | 1996 | — |
| +1 | K040268 | Depuy Preservation Unicondylar Tibia | DePuy Orthopaedics, Inc. | 2004 | 10 |
| +2 | K063432 | Conformis Metal Backed Tibial Component (MBT) | Conformis, Inc. | 2007 | 3 |
| +2 | K072368 | Conformis Metal Backed Tibial Component | Conformis, Inc. | 2007 | 3 |
| +3 | K092441 | Modification to: Conformis Iuni Unicondylar Knee Repair System | Conformis, Inc. | 2009 | — |
| +3 | K111916 | Conformis Iuni Unicondylar Knee Replacement System | Conformis, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | P.F.C.® Uni-compartmental Knee System Named without a submission number |
What descends from it? (60)
See all 602 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?
- Of its descendants, K040268 (DePuy Orthopaedics, Inc., 2004) has gone furthest, with 47 descendants 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.
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 P.F.C.® §, Uni-Compartmental Knee System is indicated for use as a uni-compartmental knee replacement for patients suffering from severe pain and disability due to structural damage caused by advanced femoral-tibial uni-compartmental degenerative arthritis resulting from primary osteoarthritis or trauma. The device is also indicated for use in patients with osteochondritis dissecans of the femoral or tibial condyle. The system is indicated for use only 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/K954481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954481: P.F.C. Uni-Compartmental 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/K954481
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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