510(k) · Cleared

Cleared

Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM

K094035510(k) TraditionalCleared Mar 24, 2011449-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

Stelkast Company · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Cleared on Mar 24, 2011 as substantially equivalent to K935484 (Stelkast Company, 1994) and 3 other predicates after a 449-day review. Its family tree reaches back 3 generations to 1981. 79 later devices descend from it.

Decided: Mar 24, 2011
Review: 449 days
Class: Class II
Product code: OQG
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K810258 (1981). 8 ancestors in all. 79 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 3 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
2 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
1 generation backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
This deviceK094035 Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded…Stelkast Company · 2011
Descendant · cites it directly · 53 of its ownK112802 Pipeline Total Hip SystemPipeline Orthopedics · 2012
Descendant · 2 generations on · 21 of its ownK122158 PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012
Descendant · 3 generations on · 20 of its ownK131237 Pipeline Total Hip SystemPipeline Orthopedics · 2013
Descendant · 4 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
Descendant · 2 generations on · 17 of its ownK162719 iTotal® Hip Replacement SystemConformis, Inc. · 2017 · Recalled

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2012high 10 (2022) · low 2 (2015)2026

Most influential descendants

Showing 5 of 79 · See all

K112802Pipeline Total Hip SystemPipeline Orthopedics · 2012 · cites it directly53descendants
K122158PBP Total Hip SystemPipeline Biomedical Products, LLC · 2012 · 2 generations on21descendants
K131237Pipeline Total Hip SystemPipeline Orthopedics · 2013 · 3 generations on20descendants
K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 4 generations on19descendants
K162719iTotal® Hip Replacement SystemConformis, Inc. · 2017 · 2 generations on17descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−2	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−1	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
0 (this device)	K094035	Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM	Stelkast Company	2011	—
+1	K112802	Pipeline Total Hip System	Pipeline Orthopedics	2012	—
+2	K122158	PBP Total Hip System	Pipeline Biomedical Products, LLC	2012	—
+3	K131237	Pipeline Total Hip System	Pipeline Orthopedics	2013	—
+4	K161184	iNSitu Total Hip System	Theken Companies, LLC	2016	—
+2	K162719	iTotal® Hip Replacement System	Conformis, Inc.	2017	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	2	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	4	0
2013	6	0
2014	3	0
2015	2	0
2016	3	0
2017	5	0
2018	3	0
2019	7	0
2020	3	0
2021	6	0
2022	10	0
2023	10	0
2024	5	0
2025	5	0
2026	7	0

FIG. 1 — Lineage of K094035, 1981–2026Source: 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 OQG? 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 OQG device

#1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 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? (4)

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
*	K935484	Provident Hip System Summary page 2 …5 10(k) demonstrates the substantial equivalence of the EXp Acetabular Liner to the following predicate devices: Acetabular Liners in the Stelkast Provident Hip System (K935484) and the Stelkast ProForm Hip System (K950827); Biomet RingLoc Acetabular Component with ArCom Polyethylene (K032396 and K970501)…	Stelkast Company	1994	—
*	K950827	Proform Porous Acetabular Assembly Summary page 2 …nce of the EXp Acetabular Liner to the following predicate devices: Acetabular Liners in the Stelkast Provident Hip System (K935484) and the Stelkast ProForm Hip System (K950827); Biomet RingLoc Acetabular Component with ArCom Polyethylene (K032396 and K970501). Previously cleared polyethylene acetabular l…	Stelkast Company	1995	—
*	K032396	Ringloc 36MM Line and Modular Femoral Heads Summary page 2 …tabular Liners in the Stelkast Provident Hip System (K935484) and the Stelkast ProForm Hip System (K950827); Biomet RingLoc Acetabular Component with ArCom Polyethylene (K032396 and K970501). Previously cleared polyethylene acetabular liners to which Vitamin F has been added include the Biomet E-Poly (Vita…	Biomet, Inc.	2003	3
*	K970501	Pegged Acetabular Component Summary page 2 …rs in the Stelkast Provident Hip System (K935484) and the Stelkast ProForm Hip System (K950827); Biomet RingLoc Acetabular Component with ArCom Polyethylene (K032396 and K970501). Previously cleared polyethylene acetabular liners to which Vitamin F has been added include the Biomet E-Poly (Vitamin E) Aceta…	Biomet, Inc.	1997	—
†	K050327	E-Poly (Vitamin E) Acetabular Liners	Biomet, Inc.	2005	—

Also cleared against K935484: 4 other devices →

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K112802	Pipeline Total Hip System	Pipeline Orthopedics	2012	53
K141972	Klassic HD Acetabular Insert with E-Link Poly	Total Joint Orthopedics, Inc.	2014	14
K112897	Renovis Surgical Hip Joint Replacement Prosthesis	Renovis Surgical Technologies, LLC	2012	8
K122773	Cross-Over Acetabular Shell & Liner	Stelkast Company	2012	6
K122883	Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System	Stelkast Company	2013	4
K190535	BiMobile Dual Mobility System - E-Dur Inserts	Waldemar Link GmbH & Co. KG	2019	3
K190276	Provident II Hip Stem	Stelkast, Inc.	2019	2
K243456	ONVOY™ Acetabular System	Globus Medical, Inc.	2025	0
K130652	Vitalite E Cross-Linked Polyethylene Acetabular Insert	Consensus Orthopedics, Inc.	2013	0
K122783	Plasmafit Acetabular Cup and Vitelene Insert	Aesculap Implant System, Inc.	2013	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 30 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
2 of the 8 ancestors have a recall of any class.
Of its descendants, K112802 (Pipeline Orthopedics, 2012) has gone furthest, with 53 descendants of its own.
4 other devices also cite its predicate K935484.

How does its category compare?

All OQG devices

OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OQG

2in 2021

2007high 5 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OQG

99in 2017

2007high 280 (2013) · low 99 (2014)2026

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

Recalls per year · OQG

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OQG

16in 2025

2007high 178 (2020) · low 0 (2007)2025

MAUDE reports naming product code OQG, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	5	144	0	0
2013	3	280	1	5
2014	3	99	0	31
2015	1	—	0	52
2016	0	—	0	45
2017	3	99	0	27
2018	0	—	0	43
2019	0	—	0	104
2020	2	—	0	178
2021	2	—	0	88
2022	0	—	0	32
2023	0	—	0	18
2024	0	—	0	20
2025	0	—	0	16
2026	0	—	0	—

What is it indicated for?

1. Non-inflammatory degenerative joint disease including osteoarthritis and

avascular necrosis.

2. Rheumatoid arthritis.

3. Correction of functional deformity.

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of

the proximal femur with head involvement, unmanageable using other

techniques.

5. Revision of previously failed total hip Arthroplasty.

Cemented and Uncemented Applications

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K094035 · printed Nov 6, 2026

Cite this page

510(k) Report. “K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K094035

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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