510(k) · Cleared
Recalled · Class II · 2016Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX
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 Nov 4, 2004 as substantially equivalent to K973714 (Zimmer, Inc., 1997) after a 29-day review. Its family tree reaches back 2 generations to 1994. 11 later devices descend from it. It has been recalled once.
- Decided
- Nov 4, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931641 (1994). 4 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 1 generation backK973714 Versys Hip System Beaded Hip ProsthesisZimmer, Inc. · 1997 · Recalled
- This deviceK042776 Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis…Zimmer, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK061786 Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 3 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · 3 generations on · 3 of its ownK210678 implaFit® hip stemsImplantcast GmbH · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K061786Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006 · cites it directly10descendants
- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 2 generations on9descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 3 generations on5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 3 generations on4descendants
- K210678implaFit® hip stemsImplantcast GmbH · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −1 | K973714 | Versys Hip System Beaded Hip Prosthesis | Zimmer, Inc. | 1997 | 8 |
| 0 (this device) | K042776 | Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model… | Zimmer, Inc. | 2004 | — |
| +1 | K061786 | Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis | Zimmer, Inc. | 2006 | — |
| +2 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +3 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +3 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +3 | K210678 | implaFit® hip stems | Implantcast GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 24.3 · 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? (1)
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 |
|---|---|---|---|
| * | K973714 | Versys Hip System Beaded Hip ProsthesisSummary page 1…21 CFR § 888.3358 Predicate Device: VerS ivs Hip System Beaded Hip Prosthesis, manufactured by Zimmer, K9737 14, cleared December 24, 1997 Device Description: Like its predicate, thle Ve… | 1997 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061786 | Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis | 2006 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 11, 2016 | Class II | Z-0846-2016 | Process control | LDPE bag containing the implant adheres to the highly polished implant surface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K061786 (Zimmer, Inc., 2006) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K973714.
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 VerSys Beaded MidCoat Low Head Center Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for: Total hip replacement for the following: 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…
Read the full statement (144 words)
The VerSys Beaded MidCoat Low Head Center Hip Prosthesis is designed to achieve
biologic fixation to bone and is indicated for:
Total hip replacement for the following: 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.
Hremi-hip replacement for the following: 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 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 as stated in the FDA summary.
https://510kreport.com/device/K042776 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042776: Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042776
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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