510(k) · Cleared

Recalled · Class II · 2017

Versys Hip System Beaded Hip Prosthesis

K973714510(k) TraditionalCleared Dec 24, 199786-day reviewClass II21 CFR 888.3358Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Dec 24, 1997 as substantially equivalent to K953337 (Zimmer, Inc., 1996) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1994. 18 later devices descend from it. It has been recalled 8 times.

Decided: Dec 24, 1997
Review: 86 days
Class: Class II
Product code: LPH
Recalls: 8
Predicates: 3

Its longest line of descent runs back 1 generation to K931641 (1994). 3 ancestors in all. 18 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
This deviceK973714 Versys Hip System Beaded Hip ProsthesisZimmer, Inc. · 1997
Descendant · cites it directly · 11 of its ownK042776 Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis…Zimmer, Inc. · 2004 · Recalled
Descendant · 2 generations on · 10 of its ownK061786 Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006
Descendant · 3 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Descendant · 4 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
Descendant · 4 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2003high 3 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 18 · See all

K042776Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XXZimmer, Inc. · 2004 · cites it directly11descendants
K061786Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006 · 2 generations on10descendants
K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 3 generations on9descendants
K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 4 generations on5descendants
K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931641	Porocoat Porous Coating	Depuy, Inc.	1994	—
0 (this device)	K973714	Versys Hip System Beaded Hip Prosthesis	Zimmer, Inc.	1997	—
+1	K042776	Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model…	Zimmer, Inc.	2004	1
+2	K061786	Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis	Zimmer, Inc.	2006	—
+3	K163577	Ecofit® Hip System	Implantcast GmbH	2017	1
+4	K180263	EcoFit Vit E Acetabular System	Implantcast GmbH	2018	—
+4	K203420	EcoFit® Hip System	Implantcast GmbH	2021	—

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
2003	2	0
2004	1	0
2006	2	0
2017	1	0
2018	1	0
2020	2	0
2021	1	0
2022	1	0
2023	2	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K973714, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K953337	Beta Hip Prosthesis Summary page 2 …emi-constrained porous-coated uncemented prosthesis éf\\é‘; A Bristol-Myers Squibb Company ey Predicate Devices: - Beta System, manufactured by Zimmer, K953337, cleared January 22, 1996 - AML Total Hip System with Porocoat, manufactured by DePuy, P820024, approved for use without bone ce…	Zimmer, Inc.	1996	15
*	P820024	Prosthesis, Hip, Hemi-Femoral, Metal FDA lists this PMA only through its supplements; the earliest we hold is P820024/S001 (Mar 16, 1984). Summary page 2 …Predicate Devices: - Beta System, manufactured by Zimmer, K953337, cleared January 22, 1996 - AML Total Hip System with Porocoat, manufactured by DePuy, P820024, approved for use without bone cement August 19, 1993, (formerly called the Porocoat Modified Austin-Moore Total Hip Prosthesis);…	Depuy, Inc.		—
*	K931641	Porocoat Porous Coating Summary page 2 …DePuy, P820024, approved for use without bone cement August 19, 1993, (formerly called the Porocoat Modified Austin-Moore Total Hip Prosthesis); Porocoat Porous Coating, K931641, cleared for use without bone cement March 21, 1994 - Prodigy Hip Prosthesis, manufactured by DePuy, K931641, cleared March 21,…	Depuy, Inc.	1994	—

Also cleared against K953337: 3 other devices →

What descends from it? (18)

See all 18

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K042776	Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XX	Zimmer, Inc.	2004	11
K060040	Zimmer M/L Taper Hip Prosthesis	Zimmer, Inc.	2006	3
K030079	Versys Beaded Fullcoat Bowed Revision Hip Prosthesis	Zimmer, Inc.	2003	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 29, 2017	Class II	Z-1026-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1023-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1025-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1022-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Nov 29, 2017	Class II	Z-1024-2018	Packaging	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
Aug 1, 2017	Class II	Z-0722-2018	Package design/selection	The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Jan 11, 2016	Class II	Z-0848-2016	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.
May 19, 2014	Class II	Z-1842-2014	Nonconforming Material/Component	During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K042776 (Zimmer, Inc., 2004) has gone furthest, with 11 descendants of its own.
3 other devices also cite its predicate K953337.

How does its category compare?

All LPH devices

LPH 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

2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007high 410 (2021) · low 76 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPH

4in 2025

2007high 30 (2012) · low 1 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPH

6,163in 2025

2007high 7,130 (2019) · low 509 (2007)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 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…

Read the full statement (140 words)

The VerSys Beaded 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 endoprotheses and/or total hip components in the affected extremity, and acute femoral neck fractures.

Hemi-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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973714 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973714: Versys Hip System Beaded Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973714

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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