510(k) · Cleared

Cleared

U2 Hip Stem, TI Plasma Spray

K062978510(k) TraditionalCleared Jan 16, 2007109-day reviewClass II21 CFR 888.3360

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

United Orthopedic Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jan 16, 2007 as substantially equivalent to K000760 (Biomet, Inc., 2000) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Jan 16, 2007
Review: 109 days
Class: Class II
Product code: LWJ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K000760 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000760 Reach Femoral ComponentBiomet, Inc. · 2000
This deviceK062978 U2 Hip Stem, TI Plasma SprayUnited Orthopedic Corp. · 2007
Descendant · cites it directly · 0 of its ownK130149 U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013

Most influential descendants

Showing 1 of 1 · See all

K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000760	Reach Femoral Component	Biomet, Inc.	2000	—
0 (this device)	K062978	U2 Hip Stem, TI Plasma Spray	United Orthopedic Corp.	2007	—
+1	K130149	U2 Hip System, Expanded Indications for Use	United Orthopedic Corporation	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K062978, 2000–2013Source: 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 LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K000760	Reach Femoral Component Summary page 1 …Name: Hip joint femoral (hemi-hip) metallic cemented or unceemented prosthesis (888.3360) Predicate Device: Reach 1 Hip Stem, Ti plasma spray (K000760) United U2 HA/Ti Plasma Spray (K003237) Device Description: The U2 Hip Stem, Ti plasma spray is composed…	Biomet, Inc.	2000	—
*	K003237	U2 Hip Stem, TI Porous Coated Summary page 1 …emented prosthesis (888.3360) Predicate Device: Reach 1 Hip Stem, Ti plasma spray (K000760) United U2 HA/Ti Plasma Spray (K003237) Device Description: The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate w…	United Orthopedic Corp.	2001	—

Also cleared against K000760: 4 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
K130149	U2 Hip System, Expanded Indications for Use	United Orthopedic Corporation	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?

None of the 2 ancestors has a recall.
Of its descendants, K130149 (United Orthopedic Corporation, 2013) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K000760.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · LWJ

1in 2012

2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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	2	—	10	68
2008	1	—	2	72
2009	1	—	2	84
2010	0	—	0	132
2011	1	—	0	255
2012	1	—	0	390
2013	0	—	1	522
2014	0	—	0	452
2015	0	—	0	310
2016	0	—	0	293
2017	0	—	0	311
2018	0	—	0	227
2019	0	—	0	210
2020	0	—	0	189
2021	0	—	0	155
2022	0	—	0	91
2023	0	—	2	72
2024	0	—	0	54
2025	0	—	0	51
2026	0	—	0	—

What is it indicated for?

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; Inflammatory degenerative joint disease such as rheumatoid arthritis; Correction of function deformity; Revision procedures where other…

Read the full statement (97 words)

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

Inflammatory degenerative joint disease such as rheumatoid arthritis;

Correction of function deformity;

Revision procedures where other treatments or devices have failed; and

Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

This device is a single use implant and intended for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062978 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062978: U2 Hip Stem, TI Plasma Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062978

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