510(k) · Cleared

Cleared

Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert

K121636510(k) TraditionalCleared Oct 24, 2012142-day reviewClass II21 CFR 888.3358

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

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

Cleared on Oct 24, 2012 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 5 other predicates after a 142-day review. Its family tree reaches back 8 generations to 1993. 1 later device descends from it.

Decided: Oct 24, 2012
Review: 142 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 6

Its longest line of descent runs back 8 generations to K930712 (1993). 129 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 8 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
7 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
6 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
5 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
4 generations backK031110 Apex Modular Acetabular CupApex Surgical, LLC · 2003
3 generations backK060635 Consensus Acetabular Shell SystemHayes Medical, Inc. · 2006
2 generations backK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
1 generation backK111472 Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head…Tgm Medical · 2011
This deviceK121636 Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head…Tgm Medical, Inc. · 2012
Descendant · cites it directly · 0 of its ownK150576 TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K930712	P.F.C. Total Hip System Porous Coated Modular	Johnson & Johnson Orthopaedics, Inc.	1993	—
−7	K983014	Summit Acetabular System	Johnson & Johnson Professionals, Inc.	1998	—
−6	K000306	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	1
−5	K001534	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	—
−4	K031110	Apex Modular Acetabular Cup	Apex Surgical, LLC	2003	—
−3	K060635	Consensus Acetabular Shell System	Hayes Medical, Inc.	2006	—
−2	K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	2010	—
−1	K111472	Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr…	Tgm Medical	2011	—
0 (this device)	K121636	Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert	Tgm Medical, Inc.	2012	—
+1	K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1983	1	0
1984	1	0
1985	2	0
1986	2	0
1987	2	0
1988	1	0
1990	1	0
1991	2	0
1992	3	0
1993	1	0
1994	18	0
1995	9	0
1996	15	0
1997	9	0
1998	6	0
1999	6	0
2000	7	0
2001	6	0
2002	8	0
2003	11	0
2004	2	0
2005	2	0
2006	2	0
2007	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K121636, 1993–2015Source: 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 24.2 · 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? (6)

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
*	K922561	Consensus (TM) Total Hip System Summary page 2 …centralizer to TOM Medical for use as the ZHS femoral components. These CHS stem designs were modified from the predicate CHS stem components cleared under K935 193 and K922561Ito incorporate neck reliefs. The distal centralizer is identical to that cleared under K922561. All ZHS implant components are co…	U.S. Medical Products, Inc.	1993	—
*	K935193	Consensus Hip System- Porous Coated Titianium Femoral Stem Summary page 2 …ir CHS distal centralizer to TOM Medical for use as the ZHS femoral components. These CHS stem designs were modified from the predicate CHS stem components cleared under K935 193 and K922561Ito incorporate neck reliefs. The distal centralizer is identical to that cleared under K922561. All ZHS implant compo…	U.S. Medical Products, Inc.	1994	—
*	K032396	Ringloc 36MM Line and Modular Femoral Heads Summary page 3 …- Porous U..MdclPoutI. 0/1/94 K935193 Coated Titanium Femoral StemU..MdclPoutI. 81/94 K032396 RingLoc 36mm Liners and Modular Biomet, Inc. 0/120 Femoral Heads K070061…	Biomet, Inc.	2003	3
*	K070061	36MM Cocr Femoral Head and 36MM Acetabular Insert Summary page 2 …screws cleared under K 111472 (Consensus had licensed their TaperSet Hip to TOM for the HHS). COI licensed the predicate CHS 36mm CoCr femoral head design cleared under K070061 and a mating 36mm UHMWPE insert design to TOM Medical for use as part of the ZHS. The ZHS 36mm heads are identical in material an…	Hayes Medical, Inc.	2007	—
*	K060918	Excia Total Hip System 12/14 Trunnion with Ceramic Head Summary page 3 …ral Heads K070061 36mm CoCr Femoral Head andHaeMdilIc 36mm [crosslinked] Acetabular Insert 01/31/2007** K060918 Excia Total Hip Aesculap, Inc. 05/26/2006 1K1 11472j Helicon Hip System…	Aesculap, Inc.	2006	—
*	K111472	Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip… Summary page 2 …ical to that cleared under K922561. All ZHS implant components are compatible with all HHS femoral heads, acetabular components, and cancellous bone screws cleared under K 111472 (Consensus had licensed their TaperSet Hip to TOM for the HHS). COI licensed the predicate CHS 36mm CoCr femoral head design cle…	Tgm Medical	2011	—

Also cleared against K922561: 10 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150576	TGM Biolox delta Ceramic Heads	Tgm Medical, Inc.	2015	0

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 19 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
24 of the 128 ancestors have a recall of any class.
Of its descendants, K150576 (Tgm Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
10 other devices also cite its predicate K922561.

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. 2012, this device’s year, is highlighted.

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 ZENITH Hip. System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System. The indications for use are: A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. C. Proximal femoral fractures. D. Avascular necrosis of the…

Read the full statement (129 words)

The ZENITH Hip. System is designed for total hip arthroplasty and is intended to be used with compatible components (femoral heads and acetabular cups) of the Helicon Hip System.

The indications for use are:

A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.

B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.

C. Proximal femoral fractures.

D. Avascular necrosis of the femoral head.

E. Non-union of proximal femoral neck fractures.

F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomnalacia, osteoporosis, pseudlarthrosis conversion, and structural abnormalities.

The un-coated stem in the ZENITH Hip System is indicated for cemented use while the porous coated stem is indicated for non-cemented use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121636: Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121636

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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