510(k) · Cleared
ClearedSHP Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers
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 Sep 17, 1996 after a 190-day review. The FDA summary names its predicate without a number. 161 later devices descend from it.
- Decided
- Sep 17, 1996
- Review
- 190 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 0
161 later devices descend from it, 1 citing it directly.
- This deviceK960984 SHP Hip System-Femoral Components/Acetabular Components/Modular…Biomet, Inc. · 1996
- 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) | K960984 | SHP Hip System-Femoral Components/Acetabular Components/Modular… | Biomet, Inc. | 1996 | — |
| +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), 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 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? (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 |
|---|---|---|---|
| * | — | Rx90 Total Hip System Named without a submission number | |
| * | — | Centralign Precoat Hip Prosthesis Named without a submission number | |
| * | — | Ranawat/Burstein Cemented Primary Series Named without a submission number | |
| * | — | Buchalter/Fauser Femoral Component Named without a submission number | |
| * | — | Premise Total Hip System Named without a submission number |
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 | — |
What is it indicated for?
Indications for use of the SHP Hip System include: 1) non inflammatory joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision of failed joint reconstruction, and 5) treatment of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement which are unmanageable using other techniques.
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/K960984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960984: SHP Hip System-Femoral Components/Acetabular Components/Modular Heads/Centralizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960984
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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