510(k) · Cleared
ClearedNatural Hip System - DRG Hip Stem
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 15, 1996 as substantially equivalent to K894051 (Intermedics Orthopedics, 1989) after a 67-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 15, 1996
- Review
- 67 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K894051 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK894051 Premier-Total HipIntermedics Orthopedics · 1989
- This deviceK961799 Natural Hip System - DRG Hip StemIntermedics Orthopedics · 1996
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) | K961799 | Natural Hip System - DRG Hip Stem | Intermedics Orthopedics | 1996 | — |
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? (4)
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…ubstantially equivalent to the features smployed by the following predicate legally marketed devices: || Premier Total Hip Stem: Intermedics Orthopaedics Inc. (510(k) #K894051). | Osteonics ODC Cemented Hip Stem: Osteonics Corporation (510(k) number unknown o IOI). | Osteonics ODC Hip Stem: Osteonics C… | 1989 |
| * | — | Osteonics ODC Cemented Hip Stem Named without a submission number | |
| * | — | Osteonics ODC Hip Stem Named without a submission number | |
| * | — | Pertecta IMC Stem Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K894051.
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?
The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty.
The general indications associated with the use of DRG Stem in total hip arthroplasty include:
1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (ID), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
3 Revision of previously failed arthroplasty.
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/K961799 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961799: Natural Hip System - DRG Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961799
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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