510(k) · Cleared
ClearedVersys Hip System--Fiber Metal Taper Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 13, 1997 as substantially equivalent to K901687 (Med-Tek Corp., 1990) and 3 other predicates after a 78-day review. Its family tree reaches back 2 generations to 1985. 1 of the 370 devices in its family, counting itself, has a Class I recall. 363 later devices descend from it.
- Decided
- Feb 13, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K850055 (1985). 6 ancestors in all. 363 later devices descend from it, 7 citing it directly. 1 of the 370 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 1 generation backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- This deviceK964769 Versys Hip System--Fiber Metal Taper Hip ProsthesisZimmer, Inc. · 1997
- Descendant · cites it directly · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 4 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
Showing 5 of 363 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K071856 Zimmer M/L Taper Hip Prosthesis with Kinectiv…3 generations on · 2007
Most influential descendants
Showing 5 of 363 · See all- K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · cites it directly296descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 2 generations on267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 3 generations on166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 4 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −1 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| 0 (this device) | K964769 | Versys Hip System--Fiber Metal Taper Hip Prosthesis | Zimmer, Inc. | 1997 | — |
| +1 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| +2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +4 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 1 |
| 2008 | 11 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 17 | 0 |
| 2012 | 28 | 0 |
| 2013 | 26 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 20 | 0 |
| 2018 | 22 | 0 |
| 2019 | 23 | 0 |
| 2020 | 24 | 0 |
| 2021 | 19 | 0 |
| 2022 | 18 | 0 |
| 2023 | 20 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 23 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K901687 | F-24 Femoral Hip ProsthesisSummary page 1…olymer/metal semiconstrained porous coated uncemented prosthesis . Predicate Devices for the Femoral Stem: - Astel F-24 Femoral Hip Prosthesis, manufactured by Zimmer, K901687, cleared September 7, 1990 - MultiLock® Hip Prosthesis, K921308, cleared February 22, 1994 - Zimmer® Anatomic Hip Prosthesis, K9… | 1990 |
| * | K921308 | HG Multilock Hip Prosthesis W/ TI-NidiumSummary page 1…. Predicate Devices for the Femoral Stem: - Astel F-24 Femoral Hip Prosthesis, manufactured by Zimmer, K901687, cleared September 7, 1990 - MultiLock® Hip Prosthesis, K921308, cleared February 22, 1994 - Zimmer® Anatomic Hip Prosthesis, K922071, cleared February 22, 1994 - Delta Hip Prosthesis, K961378… | 1994 |
| * | K922071 | Zimmer Anatomic Hip SystemSummary page 1…rosthesis, manufactured by Zimmer, K901687, cleared September 7, 1990 - MultiLock® Hip Prosthesis, K921308, cleared February 22, 1994 - Zimmer® Anatomic Hip Prosthesis, K922071, cleared February 22, 1994 - Delta Hip Prosthesis, K961378, cleared October 8, 1996 54 % A Bristol-Myers Squibb Company === P… | 1994 |
| * | K961378 | Delta Hip ProsthesisSummary page 1…r 7, 1990 - MultiLock® Hip Prosthesis, K921308, cleared February 22, 1994 - Zimmer® Anatomic Hip Prosthesis, K922071, cleared February 22, 1994 - Delta Hip Prosthesis, K961378, cleared October 8, 1996 54 % A Bristol-Myers Squibb Company Device Description The Fiber Metal Taper Hip Pros… | 1996 |
What descends from it? (363)
See all 3637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | 2003 | 296 |
| K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | 2003 | 84 |
| K163577 | Ecofit® Hip System | 2017 | 9 |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | 2016 | 3 |
| K051491 | Trabecular Metal Primary Hip Prosthesis | 2005 | 2 |
| K984492 | Tigran Hip Prosthesis | 1999 | 0 |
| K982812 | G2 Total Hip System Femoral Stem (11/13 Taper) | 1998 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series ( Modular Necks)…Zimmer, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K030733 (Zimmer, Inc., 2003) has gone furthest, with 296 descendants of its own.
- 1 other device also cites its predicate K901687.
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?
The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following: - Total Hip Replacement: Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia…
Read the full statement (159 words)
The Fiber Metal Taper Hip Prosthesis is a femoral stem designed for implantation into the human femur in either total hip or hemi-hip replacement and is indicated for the following:
- Total Hip Replacement:
Severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
- Hemi-Hip Replacement:
Fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
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/K964769 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964769: Versys Hip System--Fiber Metal Taper 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/K964769
Report an extraction error
Are you the manufacturer?
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