510(k) · Cleared
ClearedNatural Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intermedics Orthopedics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Jul 12, 1996 as substantially equivalent to K894051 (Intermedics Orthopedics, 1989) after a 176-day review. Its family tree reaches back 1 generation to 1989. 6 later devices descend from it.
- Decided
- Jul 12, 1996
- Review
- 176 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894051 (1989). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK894051 Premier-Total HipIntermedics Orthopedics · 1989
- This deviceK960258 Natural Hip SystemIntermedics Orthopedics · 1996
- Descendant · cites it directly · 5 of its ownK172857 Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK180973 Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK253171 Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK222436 Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK192989 Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2018 · cites it directly5descendants
- K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc. · 2018 · 2 generations on3descendants
- K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc. · 2026 · 3 generations on0descendants
- K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd. · 2023 · 2 generations on0descendants
- K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894051 | Premier-Total Hip | Intermedics Orthopedics | 1989 | — |
| 0 (this device) | K960258 | Natural Hip System | Intermedics Orthopedics | 1996 | — |
| +1 | K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +2 | K180973 | Libertas Hip Replacement System | Maxx Orthopedics, Inc. | 2018 | — |
| +3 | K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026 | — |
| +2 | K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt., Ltd. | 2023 | — |
| +3 | K192989 | Libertas E-XLPE Modular Liner | Maxx Orthopedics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K894051 | Premier-Total HipSummary page 1…substantially equivalent to the features employed by the following 1legally marketed predicate devices: n Prem.er Total Hip Stem: Intermedics Orthopaedics Inc. (510(k) #K894051). | Osteonics ODC Cemented Hip Stem: Osteonics Corporation (510(k) number unknown to IOI). | Osteonics ODC Hip Stem: Osteonics… | 1989 |
| * | — | Osteonics ODC Cemented Hip Stem Named without a submission number | |
| * | — | Osteonics ODC Hip Stem Named without a submission number | |
| * | — | PFC Cemented Hip Stem Named without a submission number | |
| * | — | Perfecta IMC Stem Named without a submission number | |
| † | K913060 | Natural Porous Hip System | 1991 |
| † | K942330 | Apr II Femoral Component (Various) | 1994 |
| † | K942406 | Option Shell | 1994 |
| † | K913208 | Apr II Non-Porous Hip Stem | 1991 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172857 | Latitud Hip Replacement System | 2018 | 5 |
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?
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?
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g.. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the…
Read the full statement (108 words)
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g.. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
3. Revision of previously failed arthroplasty.
Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient (see "Warnings and Precautions"), and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.
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/K960258 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960258: Natural Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960258
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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