510(k) · Cleared
ClearedE-XPE Acetabular Components and U-Motion II Acetabular Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Cleared on Jun 12, 2018 as substantially equivalent to K122185 (United Orthopedic Corp., 2013) and 5 other predicates after a 266-day review. Its family tree reaches back 12 generations to 1981. 2 later devices descend from it.
- Decided
- Jun 12, 2018
- Review
- 266 days
- Class
- Class II
- Product code
- OQI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K810258 (1981). 218 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 8 generations between
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
- Descendant · cites it directly · 1 of its ownK221149 U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
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 backK100412 Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc. · 2010
- 3 generations backK103120 Corin Biolox Delta Femoral HeadsCorin USA · 2011
- 2 generations backK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
- 1 generation backK111481 Corin Trinity Acetabular System Ecima LinersCorin USA · 2012 · Recalled
- This deviceK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
Most influential descendants
Showing 2 of 2 · See allView 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 | K100412 | Biolox Delta Ceramic Femoral Heads | Smith & Nephew, Inc. | 2010 | — |
| −3 | K103120 | Corin Biolox Delta Femoral Heads | Corin USA | 2011 | — |
| −2 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
| −1 | K111481 | Corin Trinity Acetabular System Ecima Liners | Corin USA | 2012 | 1 |
| 0 (this device) | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018 | — |
| +1 | K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | 2023 | — |
| +2 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 18 | 0 |
| 1995 | 17 | 0 |
| 1996 | 14 | 0 |
| 1997 | 12 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 20 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OQI? 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 OQI device
- #1 K252451 EPORE® XO cup systemscore 15.1 · 14 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K122185 | U-Motion II Acetabular SystemSummary page 5…Components: OQI, LZO, MEH, JDI II) U-Motion II Cup: LZO, LWJ, KWY, MEH Predicate Device 1. “UNITED” U-Motion II Acetabular System (K122185) 2.“Corin” Trinity Acetabular System ECIMA Liners (K111481)… | 2013 |
| * | K111481 | Corin Trinity Acetabular System Ecima LinersSummary page 5…1. “UNITED” U-Motion II Acetabular System (K122185) 2.“Corin” Trinity Acetabular System ECIMA Liners (K111481) 3.“Encore” X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E (K13… | 2012 |
| * | K130365 | X-Alt Highly Cross Linked VE Acetabular LinerSummary page 5…Liners (K111481) 3.“Encore” X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E (K130365) 4. “UNITED” Locking Cage, Full XPE Cup (K163441) 5. “UNITED” U2 Acetabular… | 2013 |
| * | K163441 | Locking Cage, Full XPE CupSummary page 5…ncore” X-alt™ Highly Cross Linked Acetabular Liner with Vitamin E (K130365) 4. “UNITED” Locking Cage, Full XPE Cup (K163441) 5. “UNITED” U2 Acetabular Component (K050262) 6. “UNITED” U2 Hip System (K… | 2017 |
| * | K050262 | U2 Acetabular ComponentSummary page 5…with Vitamin E (K130365) 4. “UNITED” Locking Cage, Full XPE Cup (K163441) 5. “UNITED” U2 Acetabular Component (K050262) 6. “UNITED” U2 Hip System (K111546) Reference Device “UNITED” UCP Stem (K152530) Device D… | 2005 |
| * | K111546 | U2 Hip SystemSummary page 5…ITED” Locking Cage, Full XPE Cup (K163441) 5. “UNITED” U2 Acetabular Component (K050262) 6. “UNITED” U2 Hip System (K111546) Reference Device “UNITED” UCP Stem (K152530) Device Description: For E-XPE Acetabular Components The subject E-XPE A… | 2011 |
| † | K152530 | UCP Stem | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221149 | U-Motion II Acetabular System-Extension line | 2023 | 1 |
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 37 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 58 of the 217 ancestors have a recall of any class.
- Of its descendants, K221149 (United Orthopedic Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K122185.
How does its category compare?
All OQI devicesOQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OQI
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OQI
Too few OQI 510(k)s in any year since 2007 to give a median.
Recalls per year · OQI
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQI
45in 2025
MAUDE reports naming product code OQI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 1 | 4 |
| 2023 | 0 | — | 1 | 23 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For E-XPE Cup Liner and U-Motion II Acetabular Cup The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. 2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other…
Read the full statement (199 words)
For E-XPE Cup Liner and U-Motion II Acetabular Cup
The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
2. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
4. Correction of functional deformity.
5. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cementless use only.
For E-XPE Cemented Cup
1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, 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;
5. Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.
This device is a single use implant and intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172833
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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