510(k) · Cleared
ClearedU2 Acetabular Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corp. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 15, 2005 as substantially equivalent to K994078 (United Orthopedic Corp., 2000) and 1 other predicate after a 192-day review. Its family tree reaches back 1 generation to 2000. 42 later devices descend from it.
- Decided
- Aug 15, 2005
- Review
- 192 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K994078 (2000). 2 ancestors in all. 42 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK994078 U1 Hip SystemUnited Orthopedic Corp. · 2000
- This deviceK050262 U2 Acetabular ComponentUnited Orthopedic Corp. · 2005
- Descendant · cites it directly · 23 of its ownK123705 Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · Recalled
- Descendant · cites it directly · 9 of its ownK121777 U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK182321 MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019
- Descendant · 2 generations on · 8 of its ownK152893 Corin Optimized Positioning System (OPS)Corin USA · 2016
- Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K123705Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular ShellsCorin USA · 2013 · cites it directly23descendants
- K121777U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012 · cites it directly9descendants
- K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG · 2019 · 2 generations on8descendants
- K152893Corin Optimized Positioning System (OPS)Corin USA · 2016 · 2 generations on8descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
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) | K050262 | U2 Acetabular Component | United Orthopedic Corp. | 2005 | — |
| +1 | K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | Corin USA | 2013 | 4 |
| +1 | K121777 | U2 Acetabular Cup, Plasma Spray | United Orthopedic Corp. | 2012 | 1 |
| +2 | K182321 | MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2019 | — |
| +2 | K152893 | Corin Optimized Positioning System (OPS) | Corin USA | 2016 | — |
| +1 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 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
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994078 | U1 Hip SystemSummary page 1…8.3360 Hip Joint femoral (hemi-hip) metallic Reference: cemented or uncemented prosthesis. Predicate Device: UNITED UlI Hip Prosthesis (K994078) Howmiedica Osteonics Trident(R Hemispherical acetabular shells (AD… | 2000 |
| Kept off the family tree | K013676 | FDA’s K013676 is Trident Hemispherical Acetabular Shells Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K003237 | U2 Hip Stem, TI Porous CoatedSummary page 1…Component (K0 10 170) Device Description: The U2 Acetabular Component is designated to be used with United Ul hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical desig… | 2001 |
What descends from it? (42)
See all 429 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123705 | Trinity Non-Occluded Titanium Plasma Sprayed (TPS) Acetabular Shells | 2013 | 23 |
| K121777 | U2 Acetabular Cup, Plasma Spray | 2012 | 9 |
| K122185 | U-Motion II Acetabular System | 2013 | 7 |
| K103352 | Versafitcup CC Trio | 2011 | 4 |
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | 2018 | 2 |
| K163585 | Responsive Orthopedics Total Hip Arthroplasty System | 2017 | 1 |
| K253948 | Momentum Acetabular Cup System | 2026 | 0 |
| K242315 | Resolve Modular Revision Hip Stem | 2025 | 0 |
| K130149 | U2 Hip System, Expanded Indications for Use | 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?
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 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 used 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…
Read the full statement (99 words)
This device is used 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.
The U2 Acetabular Components are designed for uncemented application and single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050262: U2 Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050262
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