510(k) · Cleared

Recalled · 2011

European Style Taper,Press-Fit Hip Stem

K062775510(k) TraditionalCleared Jan 16, 2007120-day reviewClass II21 CFR 888.3358Recalls 4

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

Ortho Development Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 16, 2007 as substantially equivalent to K043537 (Biomet, Inc., 2005) and 7 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1997. 13 later devices descend from it. It has been recalled 4 times.

Decided: Jan 16, 2007
Review: 120 days
Class: Class II
Product code: LPH
Recalls: 4
Predicates: 8

Its longest line of descent runs back 4 generations to P960047 (1997). 35 ancestors in all, the oldest K830313 (1983). 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 4 generations backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
3 generations backK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
2 generations backK030047 Freedom Constrained LinersBiomet, Inc. · 2003
1 generation backK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
This deviceK062775 European Style Taper,Press-Fit Hip StemOrtho Development Corp. · 2007
Descendant · cites it directly · 5 of its ownK131022 Ovation 10/12 Hip StemOrtho Development Corp. · 2013
Descendant · cites it directly · 4 of its ownK141001 Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014
Descendant · 2 generations on · 3 of its ownK173880 Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018
Descendant · cites it directly · 3 of its ownK133386 Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014
Descendant · 3 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013high 3 (2014) · low 0 (2015)2026

Most influential descendants

Showing 5 of 13 · See all

K131022Ovation 10/12 Hip StemOrtho Development Corp. · 2013 · cites it directly5descendants
K141001Alpine Hip Stem; Alpine HA Hip StemOrtho Development · 2014 · cites it directly4descendants
K173880Corin TriFit CF Hip StemCorin U.S.A. Limited · 2018 · 2 generations on3descendants
K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp. · 2014 · cites it directly3descendants
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	P960047	Osteonics Constrained Acetabular Insert	Howmedica Osteonics Corp.	1997	—
−3	K021728	Ringloc Constrained Liners II	Biomet, Inc.	2002	—
−2	K030047	Freedom Constrained Liners	Biomet, Inc.	2003	—
−1	K043537	Taperloc 12/14 Taper Femoral Components	Biomet, Inc.	2005	—
0 (this device)	K062775	European Style Taper,Press-Fit Hip Stem	Ortho Development Corp.	2007	—
+1	K131022	Ovation 10/12 Hip Stem	Ortho Development Corp.	2013	—
+1	K141001	Alpine Hip Stem; Alpine HA Hip Stem	Ortho Development	2014	—
+2	K173880	Corin TriFit CF Hip Stem	Corin U.S.A. Limited	2018	—
+1	K133386	Ovation Tribute Hip Stem; Ovation Narrow Hip Stem	Ortho Development Corp.	2014	—
+3	K201657	Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular…	Corin, Ltd.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1985	1	0
1986	1	0
1994	9	0
1995	3	0
1996	3	0
1997	4	0
1998	1	0
1999	3	0
2000	1	0
2001	1	0
2002	2	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	3	0
2017	2	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K062775, 1997–2026Source: 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
*	K043537	Taperloc 12/14 Taper Femoral Components Summary page 1 …ramnic/polymner semi-constrained cemented or nonporous uncemented prosthesis. (21 CFR 888.3353). Legally Marketed Device To Which Substantial Equivalence Is Claimed: K043537 - Taperloc® 12/14 Femoral Components (Biomet) K99 1485 - Synergy~m Porous Hip Stem (Smith & Nephew) K921 181, K020580, K043537, K…	Biomet, Inc.	2005	—
*	K991485	Synergy Porous Size 8 Hip Stem Summary page 1 …uncemented prosthesis. (21 CFR 888.3353). Legally Marketed Device To Which Substantial Equivalence Is Claimed: K043537 - Taperloc® 12/14 Femoral Components (Biomet) K99 1485 - Synergy~m Porous Hip Stem (Smith & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®…	Smith & Nephew, Inc.	1999	—
*	K921181	Mallory-Head Total Hip System Summary page 1 …Marketed Device To Which Substantial Equivalence Is Claimed: K043537 - Taperloc® 12/14 Femoral Components (Biomet) K99 1485 - Synergy~m Porous Hip Stem (Smith & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (…	Biomet, Inc.	1994	—
*	K020580	X-Series BI-Metric Hip Femoral Components Summary page 1 …Device To Which Substantial Equivalence Is Claimed: K043537 - Taperloc® 12/14 Femoral Components (Biomet) K99 1485 - Synergy~m Porous Hip Stem (Smith & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (Biomet) K…	Biomet, Inc.	2002	—
*	K921301	Taperloc Femoral Stem and Universal Acetabular Com Summary page 1 …bstantial Equivalence Is Claimed: K043537 - Taperloc® 12/14 Femoral Components (Biomet) K99 1485 - Synergy~m Porous Hip Stem (Smith & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (Biomet) K972228, K(020572 -…	Biomet, Inc.	1994	—
*	K972228	Meridian Titanium Femoral Stems Summary page 1 …p Stem (Smith & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (Biomet) K972228, K(020572 - Meridian®)Titanium Femoral Stems and Accolade TMZF® Femoral Stems (Howmedica) K9642 18 - Perfecta® Plasma Spray Hip S…	Howmedica, Inc.	1997	—
*	K020572	Accolade TMZF HA 132 Degree Size 0 Hip Stem Summary page 1 …th & Nephew) K921 181, K020580, K043537, K921301 - Mallory-Head® Total Hip System and Hi- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (Biomet) K972228, K(020572 - Meridian®)Titanium Femoral Stems and Accolade TMZF® Femoral Stems (Howmedica) K9642 18 - Perfecta® Plasma Spray Hip Stems (Wrig…	Howmedica Osteonics Corp.	2002	11
*	K964218	Perfecta Plasma Spray Hip Stem Summary page 1 …i- Metric®O Hip Femoral Components and Taperloc Femoral Stemns (Biomet) K972228, K(020572 - Meridian®)Titanium Femoral Stems and Accolade TMZF® Femoral Stems (Howmedica) K9642 18 - Perfecta® Plasma Spray Hip Stems (Wright Medical) Device Description: The Ovationrm Hip Stem is a one-piece, tapered prosthesi…	Wrightmedicaltechnologyinc	1997	—

Also cleared against K043537: 19 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K131022	Ovation 10/12 Hip Stem	Ortho Development Corp.	2013	5
K141001	Alpine Hip Stem; Alpine HA Hip Stem	Ortho Development	2014	4
K133386	Ovation Tribute Hip Stem; Ovation Narrow Hip Stem	Ortho Development Corp.	2014	3
K163585	Responsive Orthopedics Total Hip Arthroplasty System	Responsive Orthopedics, LLC	2017	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 11, 2011	Not classified	Z-1671-2011	Process design	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Not classified	Z-1672-2011	Process design	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Not classified	Z-1673-2011	Process design	Component of total hip arthroplasty may break during surgical procedure.
Jan 11, 2011	Not classified	Z-1670-2011	Process design	Component of total hip arthroplasty may break during surgical procedure.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
4 of the 35 ancestors have a recall of any class.
Of its descendants, K131022 (Ortho Development Corp., 2013) has gone furthest, with 5 descendants of its own.
19 other devices also cite its predicate K043537.

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. 2007, 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 OvationTM Hip Stem is used in non-cemented total hip replacement in cases

of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or

post traumatic arthritis.

2. Previously failed surgery.

3. Proximal femoral neck fractures or dislocation.

4. Idiopathic avascular necrosis of the femoral head.

5. Non-union of proximal femoral neck fractures.

6. Treatment of fractures that are unmanageable using other forms of therapy.

7. Benign or malignant bone tumors, congenital dysplasia or other structural

abnormalities where sufficient bone stock exists to properly seat the

prosthesis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062775 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062775: European Style Taper,Press-Fit Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062775

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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