510(k) · Cleared
Recalled · Class II · 2013U2 Acetabular Cup, Plasma Spray
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 Jul 18, 2012 as substantially equivalent to K050262 (United Orthopedic Corp., 2005) and 3 other predicates after a 30-day review. Its family tree reaches back 5 generations to 1994. 9 later devices descend from it. It has been recalled once.
- Decided
- Jul 18, 2012
- Review
- 30 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K941847 (1994). 24 ancestors in all, the oldest K840643 (1984). 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 4 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 3 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 2 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 1 generation backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- This deviceK121777 U2 Acetabular Cup, Plasma SprayUnited Orthopedic Corp. · 2012
- Descendant · cites it directly · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 2 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
- Descendant · 2 generations on · 2 of its ownK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · cites it directly7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 2 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 2 generations on3descendants
- K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · 2 generations on2descendants
- K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −4 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −3 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −2 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −1 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K121777 | U2 Acetabular Cup, Plasma Spray | United Orthopedic Corp. | 2012 | — |
| +1 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +2 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +2 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| +2 | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018 | — |
| +2 | K170089 | U-Motion II Acetabular System— Additional sizes | United Orthopedic Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 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 24.2 · 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? (4)
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 |
|---|---|---|---|
| * | K050262 | U2 Acetabular ComponentSummary page 1…e Class Class 11 Panel Code Orthopaedics Device Device Product Code: LPH, MEH Predicate Device: 1. "United" U2 Acetabular Component (K050262) 2. "ENCORE MEDICAL, L.P." FMPAcetabular Shell (K063257)… | 2005 |
| * | K063257 | FMP Coated Spiked Acetabular Cup; Hemispherical Acetabular Cup; Flared Rim Acetabular…Summary page 1…edicate Device: 1. "United" U2 Acetabular Component (K050262) 2. "ENCORE MEDICAL, L.P." FMPAcetabular Shell (K063257) 3. "Depuy" Pinnacle® Duofix® HA Shells (K03 1495) 4. "BIOMET®" Universale Acet… | 2006 |
| * | K031495 | Pinnacle Duofix HA Acetabular Cup ProsthesisSummary page 1…2. "ENCORE MEDICAL, L.P." FMPAcetabular Shell (K063257) 3. "Depuy" Pinnacle® Duofix® HA Shells (K03 1495) 4. "BIOMET®" Universale Acetabular Component (K92 1301) Device Descripti… | 2003 |
| * | K921301 | Taperloc Femoral Stem and Universal Acetabular ComSummary page 1…3. "Depuy" Pinnacle® Duofix® HA Shells (K03 1495) 4. "BIOMET®" Universale Acetabular Component (K92 1301) Device Description: "UNITED' U2 Acetabular Cup - Plasma Spray is an extension of cleared "UNITED" U2 Acetabular Compo… | 1994 |
What descends from it? (9)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2013 | Class II | Z-1381-2013 | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 23 ancestors have a recall of any class.
- Of its descendants, K122185 (United Orthopedic Corp., 2013) has gone furthest, with 7 descendants of its own.
- 8 other devices also cite its predicate K050262.
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. 2012, 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 devise is used 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;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed; and
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
The devise is intended for uncemented use and is single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121777: U2 Acetabular Cup, Plasma Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121777
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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