510(k) · Cleared

Cleared

Consensus CS2 Plus Acetabular Insert

K100933510(k) SpecialCleared Oct 6, 2010184-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

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

Cleared on Oct 6, 2010 as substantially equivalent to K922561 (U.S. Medical Products, Inc., 1993) and 7 other predicates after a 184-day review. Its family tree reaches back 4 generations to 1993. 35 later devices descend from it.

Decided: Oct 6, 2010
Review: 184 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 8

Its longest line of descent runs back 4 generations to K930712 (1993). 32 ancestors in all, the oldest K810258 (1981). 35 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
3 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
2 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
1 generation backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
This deviceK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
Descendant · cites it directly · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
Descendant · 2 generations on · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
Descendant · 3 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
Descendant · 4 generations on · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
Descendant · 4 generations on · 7 of its ownK172501 iNSitu Total Hip SystemTheken Companies, LLC · 2017

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2010high 5 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 35 · See all

K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · cites it directly33descendants
K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · 2 generations on20descendants
K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 3 generations on19descendants
K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · 4 generations on9descendants
K172501iNSitu Total Hip SystemTheken Companies, LLC · 2017 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K930712	P.F.C. Total Hip System Porous Coated Modular	Johnson & Johnson Orthopaedics, Inc.	1993	—
−3	K983014	Summit Acetabular System	Johnson & Johnson Professionals, Inc.	1998	—
−2	K000306	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	1
−1	K001534	Pinnacle Acetabular System	DePuy Orthopaedics, Inc.	2000	—
0 (this device)	K100933	Consensus CS2 Plus Acetabular Insert	Consensus Orthopedics, Inc.	2010	—
+1	K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	2010	—
+2	K121935	Taperset Hip Small Stems	Consensus Orthopedics, Inc.	2012	—
+3	K161184	iNSitu Total Hip System	Theken Companies, LLC	2016	—
+4	K163577	Ecofit® Hip System	Implantcast GmbH	2017	1
+4	K172501	iNSitu Total Hip System	Theken Companies, LLC	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1986	1	0
1988	1	0
1992	1	0
1993	1	0
1994	4	0
1995	4	0
1996	3	0
1997	2	0
1998	1	0
1999	2	0
2000	2	0
2001	1	0
2002	1	0
2003	1	0
2006	1	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2011	2	0
2012	5	0
2013	2	0
2015	2	0
2016	1	0
2017	3	0
2018	1	0
2019	2	0
2020	1	0
2021	1	0
2022	2	0
2023	2	0
2024	4	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K100933, 1993–2026Source: 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 24.2 · 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? (8)

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 1 …510(k) holder 5 10(k) Clearance Number Date K922561 ConsensLus Tm Total Hip System Consensus Orthopedics, Inc. 07/21/1993 K990135 Trilogy Acetabu…	U.S. Medical Products, Inc.	1993	—
*	K990135	Trilogy Acetabular System Longevity Crosslinked Polyethylene Summary page 1 …Date K922561 ConsensLus Tm Total Hip System Consensus Orthopedics, Inc. 07/21/1993 K990135 Trilogy Acetabular System Longcvity Ziminer, Inc. 07/12/1999 Crosslinked Polye…	Zimmer, Inc.	1999	—
*	K994415	Marathon Cross-Linked Polyethylene Acetabular Cup Liners Summary page 1 …07/21/1993 K990135 Trilogy Acetabular System Longcvity Ziminer, Inc. 07/12/1999 Crosslinked Polyethylene K994415 Marathon Cross-linked Polyethylene DePuy Orthopaedics, Inc. 02/03/2000 Acetabular Cup Li…	DePuy Orthopaedics, Inc.	2000	—
*	K001534	Pinnacle Acetabular System Summary page 1 …osslinked Polyethylene K994415 Marathon Cross-linked Polyethylene DePuy Orthopaedics, Inc. 02/03/2000 Acetabular Cup Liners K001534 IPinnacle Acetabular Cup System DePuy Orthopaedics, Inc. .06/12/2000 K1…	DePuy Orthopaedics, Inc.	2000	—
*	K010171	Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner Summary page 2 …Pinnacle Acetabular Cup System DePuy Orthopaedics, Inc. .06/12/2000 K1DE 0 933 K010171 Ouraloc Acetabular Cup Systemn, 36nu eu rhoadcmIc.0/620 K010171 Marathon -44 Polyethylene LinerDeyOrhpdisIn.4062…	DePuy Orthopaedics, Inc.	2001	—
*	K021466	Consensus Acetabular Insert, Cross-Linked Polyethylene Summary page 2 …0 933 K010171 Ouraloc Acetabular Cup Systemn, 36nu eu rhoadcmIc.0/620 K010171 Marathon -44 Polyethylene LinerDeyOrhpdisIn.4062! K02 1466 Consensus Acetabular Insert, T Cross- Consensus Orthopedics, Inc. 07/24/2002…	Hayes Medical, Inc.	2002	—
*	K061253	Reflection 3 Acetabular System Summary page 2 …Consensus Acetabular Insert, T Cross- Consensus Orthopedics, Inc. 07/24/2002 Linked Polyethylene (CS2 M) K061253 Reflection 3 Acetabular System Smith & Nephew 05/31/2006 K070061 36mmn CoCr Femoral Head and…	Smith & Nephew, Inc.	2006	—
*	K070061	36MM Cocr Femoral Head and 36MM Acetabular Insert Summary page 2 …pedics, Inc. 07/24/2002 Linked Polyethylene (CS2 M) K061253 Reflection 3 Acetabular System Smith & Nephew 05/31/2006 K070061 36mmn CoCr Femoral Head and 36mmn Consensus Orthopedics, Inc. 01/31/2007 K070061 Acetabular Insert (CS2TNI)…	Hayes Medical, Inc.	2007	—
†	K020153	Consensus Acetablar Shell, TI Coated	Hayes Medical, Inc.	2002	—
†	K060635	Consensus Acetabular Shell System	Hayes Medical, Inc.	2006	—
†	K933499	Consensus Hip System- Non-Porous Titanium Femoral Stem	U.S. Medical Products, Inc.	1994	—
†	K935453	Consensus (TM) Hip System-HA Coated Tianium Fem Stem	U.S. Medical Products, Inc.	1994	—
†	K935193	Consensus Hip System- Porous Coated Titianium Femoral Stem	U.S. Medical Products, Inc.	1994	—
†	K953792	Consensus Zirconia Head Size -3.5, 0, +5	U.S. Medical Products, Inc.	1995	—
†	K960156	Consensus 32MM Cocrmo Femoral Head	U.S. Medical Products, Inc.	1996	—
†	K030151	Consensus Hip System, Unisyn Hip System	Hayes Medical, Inc.	2003	—
†	K003649	Triton Hip System	Hayes Medical, Inc.	2001	—
†	K062383	Unisyn HA Plasma Modular Hip	Hayes Medical, Inc.	2006	—

Also cleared against K922561: 10 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K102399	Consensus Taperset Hip System	Consensus Orthopedics, Inc.	2010	33
K111472	Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…	Tgm Medical	2011	4
K122512	CS2 Hip System	Consensus Orthopedics, Inc.	2012	3
K130652	Vitalite E Cross-Linked Polyethylene Acetabular Insert	Consensus Orthopedics, Inc.	2013	0
K110542	Consensus Biolox Delta Ceramic Femoral Head	Consensus Orthopedics, Inc.	2011	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 17 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
7 of the 32 ancestors have a recall of any class.
Of its descendants, K102399 (Consensus Orthopedics, Inc., 2010) has gone furthest, with 33 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. 2010, 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?

In dications for use with the CONSENSUS® Hip System or UNISYN~m Hip System 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…

Read the full statement (122 words)

In dications for use with the CONSENSUS® Hip System or UNISYN~m Hip System

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, cdxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and timorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities

Acetabular components are indicated for cemented and cementless use.

Consensus femoral stems are indicated for cemented and cementless use.

UniSyn femoral stems are indicated for cementless use only.

HA coated implants are indicated for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100933 · printed Nov 5, 2026

Cite this page

510(k) Report. “K100933: Consensus CS2 Plus Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100933

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