510(k) · Cleared
ClearedU2 Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 17, 2017 as substantially equivalent to K994078 (United Orthopedic Corp., 2000) and 4 other predicates after a 266-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Jul 17, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K941847 (1994). 93 ancestors in all, the oldest K800207 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 6 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 5 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 4 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 3 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 2 generations backK060707 Aesculap Bipolar Acetabular CupAesculap, Inc. · 2006
- 1 generation backK152439 U2 Bipolar Implant and 22mm Femoral HeadUnited Orthopedic Corporation · 2016
- This deviceK162957 U2 Femoral HeadUnited Orthopedic Corporation · 2017
- Descendant · cites it directly · 0 of its ownK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −6 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −5 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −4 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −2 | K060707 | Aesculap Bipolar Acetabular Cup | Aesculap, Inc. | 2006 | — |
| −1 | K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016 | — |
| 0 (this device) | K162957 | U2 Femoral Head | United Orthopedic Corporation | 2017 | — |
| +1 | K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K994078 | U1 Hip SystemSummary page 4…he Orthopedic Panel. Device Class Class II Classification Panel Orthopaedics Product Code LPH Predicate Device 1. “United” U1 Hip System (K994078) 2. “United” U2 Acetabular Cup and Femoral Head (K022520) 3. “United” U2 Hip Syst… | 2000 |
| * | K022520 | U2 Acetabular CupSummary page 4…hopaedics Product Code LPH Predicate Device 1. “United” U1 Hip System (K994078) 2. “United” U2 Acetabular Cup and Femoral Head (K022520) 3. “United” U2 Hip System (K111546) 4.“United” Femoral Heads, 2.5 and 7.5 mm Nec… | 2003 |
| * | K111546 | U2 Hip SystemSummary page 4…1. “United” U1 Hip System (K994078) 2. “United” U2 Acetabular Cup and Femoral Head (K022520) 3. “United” U2 Hip System (K111546) 4.“United” Femoral Heads, 2.5 and 7.5 mm Neck Length (K122504)… | 2011 |
| * | K122504 | Femoral Heads, 2.5 and 7.5 MM Neck LengthSummary page 4…2520) 3. “United” U2 Hip System (K111546) 4.“United” Femoral Heads, 2.5 and 7.5 mm Neck Length (K122504) 5.“United” U2 Bipolar Implant and 22mm Femoral Head (K152439) UOC-FDA-045… | 2012 |
| * | K152439 | U2 Bipolar Implant and 22mm Femoral HeadSummary page 4…ds, 2.5 and 7.5 mm Neck Length (K122504) 5.“United” U2 Bipolar Implant and 22mm Femoral Head (K152439) UOC-FDA-045 Page: 7-1/4… | 2016 |
| † | K132207 | Utf Stem-Reduced, Additional Sizes | 2013 |
| † | K132455 | U-Motion II PS+ Cup | 2013 |
| † | K151316 | U2 Hip Stem, Ti Porous Coated, Matrix | 2015 |
| † | K152530 | UCP Stem | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221675 | United U2 femoral head, 22mm delta ceramic head | 2022 | 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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 26 of the 92 ancestors have a recall of any class.
- Of its descendants, K221675 (United Orthopedic Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K994078.
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 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 device is indicated for use in hip arthroplasty in patients with the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery.
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 as stated in the FDA summary.
https://510kreport.com/device/K162957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162957: U2 Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162957
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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