510(k) · Cleared

Cleared

Renovis Surgical Hip Joint Replacement Prosthesis

K112897510(k) TraditionalCleared Jun 13, 2012254-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

Renovis Surgical Technologies, LLC · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Cleared on Jun 13, 2012 as substantially equivalent to K030055 (Biomet, Inc., 2003) and 10 other predicates after a 254-day review. Its family tree reaches back 7 generations to 1981. 8 later devices descend from it.

Decided: Jun 13, 2012
Review: 254 days
Class: Class II
Product code: OQG
Recalls: None
Predicates: 11

Its longest line of descent runs back 7 generations to K810258 (1981). 70 ancestors in all. 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 7 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
6 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
5 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
4 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
3 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
2 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
1 generation backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
This deviceK112897 Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC · 2012
Descendant · cites it directly · 6 of its ownK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
Descendant · cites it directly · 4 of its ownK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
Descendant · 2 generations on · 1 of its ownK200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous…Kyocera Medical Technologies, Inc. · 2020
Descendant · cites it directly · 1 of its ownK143647 Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc. · 2015
Descendant · 2 generations on · 0 of its ownK242045 Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014high 2 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all

K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014 · cites it directly6descendants
K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014 · cites it directly4descendants
K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. · 2020 · 2 generations on1descendant
K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc. · 2015 · cites it directly1descendant
K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K810258	Proximal Fermoral Hip Replacement	Biomet, Inc.	1981	—
−6	K974558	Salvage/Onocology Hip and Total Femur System	Biomet, Inc.	1998	—
−5	K032396	Ringloc 36MM Line and Modular Femoral Heads	Biomet, Inc.	2003	3
−4	K042051	Arcomxl Polyethylene Liners	Biomet, Inc.	2005	1
−3	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads	Biomet, Inc.	2005	1
−2	K061312	36MM Biolox Delta Ceramic Heads	Biomet, Inc.	2006	—
−1	K073102	Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners	Biomet Manufacturing Corp	2007	—
0 (this device)	K112897	Renovis Surgical Hip Joint Replacement Prosthesis	Renovis Surgical Technologies, LLC	2012	—
+1	K132312	Renovis Tesera Trabecular Technology (T3) Acetabular Shell System	Renovis Surgical Technologies, LLC	2014	—
+1	K141676	Renovis Surgical Porous Acetabular Cup System	Renovis Surgical Technologies, Inc.	2014	—
+2	K200328	Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular…	Kyocera Medical Technologies, Inc.	2020	—
+1	K143647	Renovis Surgical Hip Replacement System	Renovis Surgical Technologies, Inc.	2015	—
+2	K242045	Initia T3 Acetabular Hemispherical Shell System	Kyocera Medical Technologies, Inc.	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0
1986	1	0
1991	1	0
1992	3	0
1993	2	0
1994	12	0
1995	6	0
1996	3	0
1997	4	0
1998	2	0
1999	2	0
2000	3	0
2001	1	0
2002	4	0
2003	4	0
2004	1	0
2005	5	0
2007	3	0
2008	1	0
2010	2	0
2011	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	2	0
2015	1	0
2017	1	0
2020	2	0
2021	1	0
2025	1	0

FIG. 1 — Lineage of K112897, 1981–2025Source: 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? (11)

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
*	K030055	Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral… Summary page 2 …A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications. Predicate Devices Predicate List 510(k) Number Manufacturer K(030055 Biomet Manufacturing K(032396 Biomet Manufacturing K(051411 Biomet Manufac…	Biomet, Inc.	2003	3
*	K032396	Ringloc 36MM Line and Modular Femoral Heads Summary page 2 …intended for cementless applications. Predicate Devices Predicate List 510(k) Number Manufacturer K(030055 Biomet Manufacturing K(032396 Biomet Manufacturing K(051411 Biomet Manufacturing K(061312 Biomet Manufac…	Biomet, Inc.	2003	3
*	K051411	Arcomxl Polyethylene Liners and Biolox Delta Heads Summary page 2 …Devices Predicate List 510(k) Number Manufacturer K(030055 Biomet Manufacturing K(032396 Biomet Manufacturing K(051411 Biomet Manufacturing K(061312 Biomet Manufacturing K(070364 Biomet Manufac…	Biomet, Inc.	2005	1
*	K061312	36MM Biolox Delta Ceramic Heads Summary page 2 …Manufacturer K(030055 Biomet Manufacturing K(032396 Biomet Manufacturing K(051411 Biomet Manufacturing K(061312 Biomet Manufacturing K(070364 Biomet Manufacturing K(073102 Biomet Manufac…	Biomet, Inc.	2006	—
*	K070364	100KGY E-Poly Maxrom Acetabular Liners Summary page 2 …omet Manufacturing K(032396 Biomet Manufacturing K(051411 Biomet Manufacturing K(061312 Biomet Manufacturing K(070364 Biomet Manufacturing K(073102 Biomet Manufacturing 2.1P a g e…	Biomet, Inc.	2007	—
*	K073102	Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners Summary page 2 …omet Manufacturing K(051411 Biomet Manufacturing K(061312 Biomet Manufacturing K(070364 Biomet Manufacturing K(073102 Biomet Manufacturing 2.1P a g e O RENOV IS K09 1956 DJO Sur…	Biomet Manufacturing Corp	2007	—
*	K091956	Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 Summary page 3 …anufacturing K(070364 Biomet Manufacturing K(073102 Biomet Manufacturing 2.1P a g e O RENOV IS K09 1956 DJO Surgical K094035 Stelast, Inc. K043537 Biomet Manufacturing K093235…	Encore Medical L.P.	2010	4
*	K094035	Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM Summary page 3 …Biomet Manufacturing K(073102 Biomet Manufacturing 2.1P a g e O RENOV IS K09 1956 DJO Surgical K094035 Stelast, Inc. K043537 Biomet Manufacturing K093235 Biomet Manufacturing…	Stelkast Company	2011	—
*	K043537	Taperloc 12/14 Taper Femoral Components Summary page 3 …Biomet Manufacturing 2.1P a g e O RENOV IS K09 1956 DJO Surgical K094035 Stelast, Inc. K043537 Biomet Manufacturing K093235 Biomet Manufacturing K(981211 Sulzer Orthopedi…	Biomet, Inc.	2005	—
*	K093235	Ringloc + Hybrid Acetabular System Summary page 3 …age 3 === O RENOV IS K09 1956 DJO Surgical K094035 Stelast, Inc. K043537 Biomet Manufacturing K093235 Biomet Manufacturing K(981211 Sulzer Orthopedics Substantial Equivalence The Renovis A400 Su…	Biomet, Inc.	2010	30
*	K981211	Apr -T Revision Hip Stem Summary page 3 …DJO Surgical K094035 Stelast, Inc. K043537 Biomet Manufacturing K093235 Biomet Manufacturing K(981211 Sulzer Orthopedics Substantial Equivalence The Renovis A400 Surgical Hip Replacement System claims substantial…	Sulzer Orthopedics, Inc.	1998	—

Also cleared against K030055: 5 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K132312	Renovis Tesera Trabecular Technology (T3) Acetabular Shell System	Renovis Surgical Technologies, LLC	2014	6
K141676	Renovis Surgical Porous Acetabular Cup System	Renovis Surgical Technologies, Inc.	2014	4
K143647	Renovis Surgical Hip Replacement System	Renovis Surgical Technologies, Inc.	2015	1
K171543	Renovis Surgical Hip Replacement System	Renovis Surgical Technologies	2017	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 31 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
18 of the 70 ancestors have a recall of any class.
Of its descendants, K132312 (Renovis Surgical Technologies, LLC, 2014) has gone furthest, with 6 descendants of its own.
5 other devices also cite its predicate K030055.

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. 2012, 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?

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is indicated for patients suffering from the following:

1. Noninflammatory 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; and

5. Revision procedures where other treatment or devices have failed.

The Renovis A400 Surgical Hip Joint Replacement Prosthesis is intended for cementless applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112897 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112897: Renovis Surgical Hip Joint Replacement Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112897

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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