510(k) · Cleared
ClearedU2 Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Feb 25, 2003 as substantially equivalent to K994078 (United Orthopedic Corp., 2000) after a 210-day review. Its family tree reaches back 1 generation to 2000. 14 later devices descend from it.
- Decided
- Feb 25, 2003
- Review
- 210 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994078 (2000). 14 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK994078 U1 Hip SystemUnited Orthopedic Corp. · 2000
- This deviceK022520 U2 Acetabular CupUnited Orthopedic Corp. · 2003
- Descendant · cites it directly · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 2 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 3 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- Descendant · cites it directly · 3 of its ownK122504 Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · cites it directly13descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 2 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 3 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 3 generations on3descendants
- K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994078 | U1 Hip System | United Orthopedic Corp. | 2000 | — |
| 0 (this device) | K022520 | U2 Acetabular Cup | United Orthopedic Corp. | 2003 | — |
| +1 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +2 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +3 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +3 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| +1 | K122504 | Femoral Heads, 2.5 and 7.5 MM Neck Length | United Orthopedic Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 24.3 · 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? (1)
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 1….3358 Hip joint metal/polymer/metal Reference: semi-constrained porous-coated uncemented prosthesis Predicate Device: UNITED U1 Hip Prosthesis (K994078) Device Description: The U2 Acetabular Cup and Femoal Head are designated as an acetabular component and femoral head… | 2000 |
What descends from it? (14)
See all 145 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
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 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; and
Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022520 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022520: U2 Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022520
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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