510(k) · Cleared
Recalled · Class II · 2018Biomet Cobalt-Chrome Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jun 27, 1991 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it. It has been recalled 12 times.
- Decided
- Jun 27, 1991
- Review
- 72 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 12
- Predicates
- 0
56 later devices descend from it, 3 citing it directly.
- This deviceK911684 Biomet Cobalt-Chrome Femoral ComponentsBiomet, Inc. · 1991
- Descendant · cites it directly · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 2 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 17 of its ownK142882 G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK221479 Persona Personalized Knee SystemZimmer, Inc. · 2022
- Descendant · 2 generations on · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · cites it directly53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 2 generations on35descendants
- K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc. · 2015 · 2 generations on17descendants
- K221479Persona Personalized Knee SystemZimmer, Inc. · 2022 · 3 generations on8descendants
- K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911684 | Biomet Cobalt-Chrome Femoral Components | Biomet, Inc. | 1991 | — |
| +1 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +2 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 | Biomet, Inc. | 2015 | — |
| +3 | K221479 | Persona Personalized Knee System | Zimmer, Inc. | 2022 | — |
| +2 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 9 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (56)
See all 563 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2018 | Class II | Z-1537-2018 | Nonconforming Material/Component | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. |
| Apr 16, 2015 | Class III | Z-1757-2015 | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. |
| Jun 18, 2003 | Not classified | Z-1285-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1282-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1283-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1281-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1290-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1288-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1287-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1284-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1286-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
| Jun 18, 2003 | Not classified | Z-1289-03 | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121874 (Biomet Manufacturing Corp, 2012) has gone furthest, with 53 descendants of its own.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K911684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911684: Biomet Cobalt-Chrome Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911684
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026