510(k) · Cleared
ClearedTitanium Femoral Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Mar 10, 1999 after a 275-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Mar 10, 1999
- Review
- 275 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK981996 Titanium Femoral ComponentBiomet, Inc. · 1999
- Descendant · cites it directly · 6 of its ownK080204 Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK171054 Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 4 of its ownK181947 Persona Revision Knee SystemZimmer, Inc. · 2018 · Recalled
- Descendant · cites it directly · 3 of its ownK041466 Titanium Femoral Knee Components (Maxim and Agc)Biomet Manufacturing Corp · 2004
- Descendant · cites it directly · 2 of its ownK063515 Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci…Biomet Manufacturing, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080204Vanguard Knee System Titanium Femoral ComponentsBiomet, Inc. · 2008 · cites it directly6descendants
- K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc. · 2017 · 2 generations on5descendants
- K181947Persona Revision Knee SystemZimmer, Inc. · 2018 · 3 generations on4descendants
- K041466Titanium Femoral Knee Components (Maxim and Agc)Biomet Manufacturing Corp · 2004 · cites it directly3descendants
- K063515Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeBiomet Manufacturing, Inc. · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981996 | Titanium Femoral Component | Biomet, Inc. | 1999 | — |
| +1 | K080204 | Vanguard Knee System Titanium Femoral Components | Biomet, Inc. | 2008 | — |
| +2 | K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | 2017 | 4 |
| +3 | K181947 | Persona Revision Knee System | Zimmer, Inc. | 2018 | 1 |
| +1 | K041466 | Titanium Femoral Knee Components (Maxim and Agc) | Biomet Manufacturing Corp | 2004 | — |
| +1 | K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II… | Biomet Manufacturing, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2025 | 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 JWH? 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 JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Maxim Knee System Named without a submission number | |
| * | — | AGC 2000 Total Knee Prosthesis Named without a submission number | |
| * | — | MG I Total Knee Named without a submission number | |
| * | — | Kinemax Plus Total Knee System Named without a submission number | |
| * | — | Genesis Total Knee System Named without a submission number |
What descends from it? (11)
See all 113 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, K080204 (Biomet, Inc., 2008) has gone furthest, with 6 descendants of its own.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, 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 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure, 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.
Device designed for use in patients with metal sensitivity.
Standard surgical and rehabilitative procedures are indicated with this device.
This device is a single use implant 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/K981996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981996: Titanium Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981996
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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