510(k) · Cleared
ClearedCfe Total Hip Femoral Component
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 May 25, 1983 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 161 later devices descend from it.
- Decided
- May 25, 1983
- Review
- 114 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
161 later devices descend from it, 1 citing it directly.
- This deviceK830313 Cfe Total Hip Femoral ComponentBiomet, Inc. · 1983
- Descendant · cites it directly · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 2 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
- Descendant · 2 generations on · 20 of its ownK121297 Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell…Signature Orthopaedics Pty, Ltd. · 2012 · Recalled
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · cites it directly160descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 2 generations on33descendants
- K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd. · 2012 · 2 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830313 | Cfe Total Hip Femoral Component | Biomet, Inc. | 1983 | — |
| +1 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +2 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
| +2 | K121297 | Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal… | Signature Orthopaedics Pty, Ltd. | 2012 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 12 | 0 |
| 2013 | 6 | 0 |
| 2014 | 13 | 0 |
| 2015 | 9 | 0 |
| 2016 | 8 | 0 |
| 2017 | 10 | 0 |
| 2018 | 5 | 0 |
| 2019 | 16 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 13 | 0 |
| 2026 | 17 | 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? (161)
See all 1611 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043537 | Taperloc 12/14 Taper Femoral Components | 2005 | 160 |
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, K043537 (Biomet, Inc., 2005) has gone furthest, with 160 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/K830313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830313: Cfe Total Hip Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830313
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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