510(k) · Cleared

Recalled · Class II · 2017

Beta Hip Prosthesis

K953337510(k) TraditionalCleared Jan 22, 1996189-day reviewClass II21 CFR 888.3358Recalls 15

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 Jan 22, 1996 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 22 later devices descend from it. It has been recalled 15 times.

Decided: Jan 22, 1996
Review: 189 days
Class: Class II
Product code: LPH
Recalls: 15
Predicates: 0

22 later devices descend from it, 4 citing it directly.

This deviceK953337 Beta Hip ProsthesisZimmer, Inc. · 1996
Descendant · cites it directly · 18 of its ownK973714 Versys Hip System Beaded Hip ProsthesisZimmer, Inc. · 1997 · Recalled
Descendant · 2 generations on · 11 of its ownK042776 Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis…Zimmer, Inc. · 2004 · Recalled
Descendant · 3 generations on · 10 of its ownK061786 Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006
Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Descendant · 5 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 22 · See all

K973714Versys Hip System Beaded Hip ProsthesisZimmer, Inc. · 1997 · cites it directly18descendants
K042776Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model 00-7840-XXX-XXZimmer, Inc. · 2004 · 2 generations on11descendants
K061786Versys Fiber Metal Midcoat Low Head Center Hip ProsthesisZimmer, Inc. · 2006 · 3 generations on10descendants
K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 5 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953337	Beta Hip Prosthesis	Zimmer, Inc.	1996	—
+1	K973714	Versys Hip System Beaded Hip Prosthesis	Zimmer, Inc.	1997	8
+2	K042776	Versys Hip System Beaded Midcoat Low Head Center Hip Prosthesis, Model…	Zimmer, Inc.	2004	1
+3	K061786	Versys Fiber Metal Midcoat Low Head Center Hip Prosthesis	Zimmer, Inc.	2006	—
+4	K163577	Ecofit® Hip System	Implantcast GmbH	2017	1
+5	K180263	EcoFit Vit E Acetabular System	Implantcast GmbH	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
2003	2	0
2004	1	0
2006	2	0
2017	1	0
2018	1	0
2019	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 K953337, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K973714	Versys Hip System Beaded Hip Prosthesis	Zimmer, Inc.	1997	18
K183457	Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head	Zimmer, Inc.	2019	0
K972690	Zirconia Ceramic Femoral Head	Zimmer, Inc.	1997	0
K971752	Zirconia Ceramic Femoral Head (12/14 Taper)	Zimmer, Inc.	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
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.
Feb 28, 2017	Class II	Z-2577-2017	Packaging	Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Feb 28, 2017	Class II	Z-2579-2017	Packaging	Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Feb 28, 2017	Class II	Z-2578-2017	Packaging	Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Feb 28, 2017	Class II	Z-2580-2017	Packaging	Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Feb 28, 2017	Class II	Z-2581-2017	Packaging	Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.
Jan 11, 2016	Class II	Z-0849-2016	Process control	LDPE bag containing the implant adheres to the highly polished implant surface.
Jan 11, 2016	Class II	Z-1127-2016	Packaging	As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Oct 11, 2013	Class II	Z-1031-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…
Oct 11, 2013	Class II	Z-1034-2014	Packaging	Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the…
Aug 30, 2013	Class II	Z-0070-2014	Package design/selection	The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Jul 5, 2010	Not classified	Z-2291-2010	Other	Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect.
Jul 5, 2010	Not classified	Z-2290-2010	Other	Zimmer, Inc. has determined that there is a potential for a package to be labeled as a 28 mm femoral head but contain a 32 mm femoral head. In addition, there is a potential for the patient record label to be incorrect.
Aug 3, 2009	Not classified	Z-0198-2010	Manufacturing material removal	Manufacturing material may be present on the surface of the implant.
Apr 15, 2005	Not classified	Z-1066-05	Other	May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.

The 5 latest of 15 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K973714 (Zimmer, Inc., 1997) has gone furthest, with 18 descendants of its own.

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	—

https://510kreport.com/device/K953337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953337: Beta 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/K953337

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026