510(k) · Cleared
ClearedUnited U2 femoral head, 22mm delta ceramic 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 Nov 4, 2022 as substantially equivalent to K162957 (United Orthopedic Corporation, 2017) and 4 other predicates after a 148-day review. Its family tree reaches back 12 generations to 1981.
- Decided
- Nov 4, 2022
- Review
- 148 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K810258 (1981). 273 ancestors in all, the oldest K800207 (1980). No later device cites it as a predicate yet.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 2 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 1 generation backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- This deviceK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
Show all 12 generations
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 11 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 10 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 9 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 8 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 7 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 6 generations backK071535 Biolox Delta Ceramic Femoral HeadZimmer, Inc. · 2007 · Recalled
- 5 generations backK082844 Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head…Encore Medical L.P. · 2008 · Recalled
- 4 generations backK100445 Klassic HD Hip SystemTotal Joint Orthopedics, Inc. · 2010
- 3 generations backK141972 Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc. · 2014
- 2 generations backK161073 Klassic HD Hip SystemTotal Joint Othopedics, Inc. · 2016
- 1 generation backK180929 Klassic HD® Hip SystemTotal Joint Orthopedics, Inc. · 2018
- This deviceK221675 United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −11 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −10 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −9 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −8 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −7 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −6 | K071535 | Biolox Delta Ceramic Femoral Head | Zimmer, Inc. | 2007 | 3 |
| −5 | K082844 | Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset… | Encore Medical L.P. | 2008 | 1 |
| −4 | K100445 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2010 | — |
| −3 | K141972 | Klassic HD Acetabular Insert with E-Link Poly | Total Joint Orthopedics, Inc. | 2014 | — |
| −2 | K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016 | — |
| −1 | K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 6 | 0 |
| 1993 | 6 | 0 |
| 1994 | 27 | 0 |
| 1995 | 20 | 0 |
| 1996 | 18 | 0 |
| 1997 | 12 | 0 |
| 1998 | 14 | 0 |
| 1999 | 16 | 0 |
| 2000 | 23 | 0 |
| 2001 | 14 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 8 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K162957 | U2 Femoral HeadSummary page 4…osthesis Predicate devices Predicate 510(k) Number Manufacturer Primary Predicate U2 Femoral Head K162957 United Orthopedic Corporation Additional Predicate Devices United 36MM Ceramic Femoral Head, Delta K112463… | 2017 |
| * | K112463 | United 36MM Ceramic Femoral Head, DeltaSummary page 4…emoral Head K162957 United Orthopedic Corporation Additional Predicate Devices United 36MM Ceramic Femoral Head, Delta K112463 United Orthopedic Corporation Ceramic Femoral Head K103497 United Orthopedic Cor… | 2011 |
| * | K103497 | Ceramic Femoral HeadSummary page 4…tional Predicate Devices United 36MM Ceramic Femoral Head, Delta K112463 United Orthopedic Corporation Ceramic Femoral Head K103497 United Orthopedic Corporation Klassic HD® Hip System K180929 Total Joint Orthopedi… | 2011 |
| * | K180929 | Klassic HD® Hip SystemSummary page 4…d Orthopedic Corporation Ceramic Femoral Head K103497 United Orthopedic Corporation Klassic HD® Hip System K180929 Total Joint Orthopedics (TJO) U-MOTION II Acetabular System K122185 United Orthopedic Co… | 2018 |
| * | K122185 | U-Motion II Acetabular SystemSummary page 4…Orthopedic Corporation Klassic HD® Hip System K180929 Total Joint Orthopedics (TJO) U-MOTION II Acetabular System K122185 United Orthopedic Corporation… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 41 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 60 of the 272 ancestors have a recall of any class.
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. 2022, 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.
In the USA: United U2 femoral head, 22mm delta ceramic head is only indicated for use with the hemi (bipolar) implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221675: United U2 femoral head, 22mm delta ceramic head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221675
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