510(k) · Cleared

Cleared

U2 Hip System, Expanded Indications for Use

K130149510(k) TraditionalCleared Jun 6, 2013135-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

United Orthopedic Corporation · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jun 6, 2013 as substantially equivalent to K994078 (United Orthopedic Corp., 2000) and 14 other predicates after a 135-day review. Its family tree reaches back 6 generations to 1994. 1 of the 73 devices in its family, counting itself, has a Class I recall.

Decided: Jun 6, 2013
Review: 135 days
Class: Class II
Product code: LPH
Recalls: None
Predicates: 15

Its longest line of descent runs back 6 generations to K941847 (1994). 73 ancestors in all, the oldest K833175 (1983). No later device cites it as a predicate yet. 1 of the 73 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 6 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
5 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
4 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
3 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
2 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
1 generation backK121777 U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012 · Recalled
This deviceK130149 U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation · 2013

Class I recalls in this family

K003016 Pro-Femur R2 generations back · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K941847	5/8 Porocoat Aml Hip Porocoat Porous Coating	Depuy, Inc.	1994	—
−5	K964650	TCP-Coated Porocoat Aml Femoral Hip Prosthesis	Depuy, Inc.	1997	—
−4	K980711	Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating	Zimmer, Inc.	1998	1
−3	K001277	Triflange Acetabular Cup System	DePuy Orthopaedics, Inc.	2000	—
−2	K031495	Pinnacle Duofix HA Acetabular Cup Prosthesis	DePuy Orthopaedics, Inc.	2003	—
−1	K121777	U2 Acetabular Cup, Plasma Spray	United Orthopedic Corp.	2012	1
0 (this device)	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
1983	1	0
1984	1	0
1986	1	0
1988	1	0
1990	1	0
1991	1	0
1992	1	0
1993	1	0
1994	6	0
1995	6	0
1996	4	0
1997	4	0
1998	4	0
1999	5	0
2000	8	1
2001	4	0
2002	1	0
2003	2	0
2004	1	0
2005	3	0
2006	4	0
2007	3	0
2010	1	0
2011	1	0
2012	1	0

FIG. 1 — Lineage of K130149, 1994–2013Source: 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.

1 device in this family has a Class I recall. 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? (15)

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
*	K994078	U1 Hip System Summary page 1 …e Device: uncemented prosthesis under 21 CFR 888.3358 This falls under the Orthopedics panel. Class II Orthopéedics Device LPH, JDI, MEH 1. “UNITED” Ul Hip System (K994078) 2. “UNITED” U2 Hip Stem, Ti porous coated (K003237) 3. “UNITED” U2 Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 A…	United Orthopedic Corp.	2000	—
*	K003237	U2 Hip Stem, TI Porous Coated Summary page 1 …8 This falls under the Orthopedics panel. Class II Orthopéedics Device LPH, JDI, MEH 1. “UNITED” Ul Hip System (K994078) 2. “UNITED” U2 Hip Stem, Ti porous coated (K003237) 3. “UNITED” U2 Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Ste…	United Orthopedic Corp.	2001	—
*	K022520	U2 Acetabular Cup Summary page 1 …opéedics Device LPH, JDI, MEH 1. “UNITED” Ul Hip System (K994078) 2. “UNITED” U2 Hip Stem, Ti porous coated (K003237) 3. “UNITED” U2 Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Stem, Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K…	United Orthopedic Corp.	2003	—
*	K050262	U2 Acetabular Component Summary page 1 …Hip System (K994078) 2. “UNITED” U2 Hip Stem, Ti porous coated (K003237) 3. “UNITED” U2 Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Stem, Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K111546) 7. “UNITED” U2 Acetabular Cup, Plasma…	United Orthopedic Corp.	2005	—
*	K062978	U2 Hip Stem, TI Plasma Spray Summary page 1 …rous coated (K003237) 3. “UNITED” U2 Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Stem, Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K111546) 7. “UNITED” U2 Acetabular Cup, Plasma Spray (K121777) 8. “UNITED” Femoral Heads, +2.5 & +…	United Orthopedic Corp.	2007	—
*	K111546	U2 Hip System Summary page 1 …Acetabular Cup and Femoral Head (K022520) 4. “UNITED” U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Stem, Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K111546) 7. “UNITED” U2 Acetabular Cup, Plasma Spray (K121777) 8. “UNITED” Femoral Heads, +2.5 & +7.5 mm Offset (K122504) UOC-FDA-026…	United Orthopedic Corp.	2011	1
*	K121777	U2 Acetabular Cup, Plasma Spray Summary page 1 …U2 Acetabular Component (K050262) 5. “UNITED” U2 Hip Stem, Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K111546) 7. “UNITED” U2 Acetabular Cup, Plasma Spray (K121777) 8. “UNITED” Femoral Heads, +2.5 & +7.5 mm Offset (K122504) UOC-FDA-026 Page: Summary-1/4 K130149 (pg 2/4) @…	United Orthopedic Corp.	2012	1
*	K122504	Femoral Heads, 2.5 and 7.5 MM Neck Length Summary page 1 …Ti Plasma Spray (K062978) 6. “UNITED” U2 Hip System (K111546) 7. “UNITED” U2 Acetabular Cup, Plasma Spray (K121777) 8. “UNITED” Femoral Heads, +2.5 & +7.5 mm Offset (K122504) UOC-FDA-026 Page: Summary-1/4 K130149 (pg 2/4) @ U2 Hip System, Expanded Indications for Use 510¢k) Summary…	United Orthopedic Corporation	2012	—
*	K021346	Stem Hip Replacement System, Model PHA002XX Summary page 3 …d do not affect the functional effectiveness and safety. Besides, the indications are substantially equivalent to legally marketed “WRIGHT” STEM Hip Replacement System (K021346), “HOWMEDICA” Stryker Modular Hip System (K071082) and “BIOMET” Medallion Modular Hip System (K041850) for total hip replacement.…	Wrightmedicaltechnologyinc	2002	3
*	K071082	Stryker Modular Hip System Summary page 3 …afety. Besides, the indications are substantially equivalent to legally marketed “WRIGHT” STEM Hip Replacement System (K021346), “HOWMEDICA” Stryker Modular Hip System (K071082) and “BIOMET” Medallion Modular Hip System (K041850) for total hip replacement. In the other hand, for bipolar hip replacement, t…	Howmedica Osteonics Corp.	2007	—
*	K041850	Medallion Modular Hip System Summary page 3 …quivalent to legally marketed “WRIGHT” STEM Hip Replacement System (K021346), “HOWMEDICA” Stryker Modular Hip System (K071082) and “BIOMET” Medallion Modular Hip System (K041850) for total hip replacement. In the other hand, for bipolar hip replacement, the indications of current submission are identical t…	Biomet Manufacturing, Inc.	2004	—
*	K050269	U1 Hip System - Bipolar Summary page 3 …041850) for total hip replacement. In the other hand, for bipolar hip replacement, the indications of current submission are identical to “UNITED” Ul Hip System-Bipolar (K050269).and “UNITED” U2 Bipolar Implant (K101670), and are also equivalent to “Smith & Nephew” Global Bipolar System (K023743) and “BIOM…	United Orthopedic Corp.	2005	—
*	K101670	United U2 Bipolar Implant Summary page 3 …other hand, for bipolar hip replacement, the indications of current submission are identical to “UNITED” Ul Hip System-Bipolar (K050269).and “UNITED” U2 Bipolar Implant (K101670), and are also equivalent to “Smith & Nephew” Global Bipolar System (K023743) and “BIOMET” RingLoc® Bi-Polar Acetabular Component…	United Orthopedic Corp.	2010	1
*	K023743	Smith & Nephew Global Bipolar System Summary page 3 …n are identical to “UNITED” Ul Hip System-Bipolar (K050269).and “UNITED” U2 Bipolar Implant (K101670), and are also equivalent to “Smith & Nephew” Global Bipolar System (K023743) and “BIOMET” RingLoc® Bi-Polar Acetabular Component (K051569). Summary of Technologies The technological characteristics (desig…	Smith & Nephew, Inc.	2003	3
*	K051569	Ringloc BI-Polar Acetabular Component Summary page 3 …d “UNITED” U2 Bipolar Implant (K101670), and are also equivalent to “Smith & Nephew” Global Bipolar System (K023743) and “BIOMET” RingLoc® Bi-Polar Acetabular Component (K051569). Summary of Technologies The technological characteristics (design, materials, packaging materials and sterilization method) o…	Biomet, Inc.	2005	4

Also cleared against K994078: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K003016Pro-Femur RWrightmedicaltechnologyinc · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
17 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
6 other devices also cite its predicate K994078.

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. 2013, 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?

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: 1. Non-inflammatory degenerative joint disease such as osteoarthritis, 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 (107 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:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, 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;

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

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K130149 · printed Nov 5, 2026

Cite this page

510(k) Report. “K130149: U2 Hip System, Expanded Indications for Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130149

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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