510(k) · Cleared
ClearedTigran Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ponmed, Ltd. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 15, 1999 as substantially equivalent to K964769 (Zimmer, Inc., 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Mar 15, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K850055 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 2 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 1 generation backK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- This deviceK984492 Tigran Hip ProsthesisPonmed, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −2 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −1 | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| 0 (this device) | K984492 | Tigran Hip Prosthesis | Ponmed, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K964769 | Versys Hip System--Fiber Metal Taper Hip ProsthesisSummary page 1…CLASSIFICATION NAME: Femoral Hip Prosthesis PREDICATE DEVICES: The Tigran ™ Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594). Device Description; The Tigran™ Femoral Prosthesis for hip arthroplasty consis… | 1997 |
| * | K915594 | Stability Hip Femoral ComponentSummary page 1…PREDICATE DEVICES: The Tigran ™ Hip Prosthesis is substantially equivalent to the Zimmer Versys Hip System (510(k) Number K 964769) and the DePuy Stability™ Hip System (K 915594). Device Description; The Tigran™ Femoral Prosthesis for hip arthroplasty consists of three basic parts: femoral heads, femoral… | 1993 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 6 other devices also cite its predicate K964769.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
1) 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
2). Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
3) Patients suffering from disability due to previous fusion;
4) Patients with previously failed endoprostheses and/or total hip components in the affected extremity;
5) Patients with acute femoral neck fractures.
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/K984492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984492: Tigran Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984492
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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