510(k) · Cleared
ClearedCPT Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 20, 2020 as substantially equivalent to K960658 (Zimmer, Inc., 1996) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 20, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- JDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960658 (1996). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960658 Collarless Polished Taper Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 1 generation backK030265 CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Zimmer, Inc. · 2003 · Recalled
- This deviceK191735 CPT Hip SystemZimmer, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK200823 Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK250834 Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960658 | Collarless Polished Taper Hip Prosthesis | Zimmer, Inc. | 1996 | 14 |
| −1 | K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00 | Zimmer, Inc. | 2003 | 3 |
| 0 (this device) | K191735 | CPT Hip System | Zimmer, Inc. | 2020 | — |
| +1 | K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | 2020 | 1 |
| +2 | K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K960658 | Collarless Polished Taper Hip ProsthesisSummary page 5…esis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350) Predicate Device(s): K960658 COLLARLESS Zimmer, Inc. POLISHED… | 1996 |
| * | K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Summary page 5…TAPER HIP PROSTHESIS K030265 CPT 12/14 HIP Zimmer, Inc. PROSTHESES,… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | 2020 | 1 |
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?
- The line of descent spans 24 years and passes through 1 company; a new generation was cleared every 17.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K200823 (Zimmer, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K960658.
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. 2020, this device’s year, is highlighted.
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 CPT Hip System is indicated for cemented use in:
– Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
– Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
– Patients suffering from disability due to previous fusion.
– Patients with previously failed endoprostheses and/or total hip components in the affected extremity.
– Patients with acute femoral neck fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191735: CPT 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/K191735
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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