510(k) · Cleared
ClearedU-Motion II Acetabular System-Extension line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United Orthopedic Corporation · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jan 5, 2023 as substantially equivalent to K122185 (United Orthopedic Corp., 2013) and 5 other predicates after a 260-day review. Its family tree reaches back 13 generations to 1996. 1 later device descends from it.
- Decided
- Jan 5, 2023
- Review
- 260 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 13 generations to K955033 (1996). 221 ancestors in all, the oldest K810258 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 9 generations between
- 3 generations backK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- 2 generations backK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- 1 generation backK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
- This deviceK221149 U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023
- Descendant · cites it directly · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Show all 13 generations
- Root · 13 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 12 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 11 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 10 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 9 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 8 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 7 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 6 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 5 generations backK083312 Minihip StemCorin USA · 2010
- 4 generations backK103518 Trinity Acetabular SystemCorin USA · 2011
- 3 generations backK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- 2 generations backK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- 1 generation backK170089 U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation · 2017
- This deviceK221149 U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023
Most influential descendants
Showing 1 of 1 · See all- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −12 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −11 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −10 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −9 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −8 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −7 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −6 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| −5 | K083312 | Minihip Stem | Corin USA | 2010 | — |
| −4 | K103518 | Trinity Acetabular System | Corin USA | 2011 | — |
| −3 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| −2 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| −1 | K170089 | U-Motion II Acetabular System— Additional sizes | United Orthopedic Corporation | 2017 | — |
| 0 (this device) | K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | 2023 | — |
| +1 | K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 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 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 19 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 5 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 4…Manufacturer 510(k) Number Primary Predicate U-Motion II Acetabular System United Orthopedic Corporation K122185 Additional Predicates U-Motion II PS+ Cup K132455 U-Motion II Acetabular… | 2013 |
| * | K132455 | U-Motion II PS+ CupSummary page 4…I Acetabular System United Orthopedic Corporation K122185 Additional Predicates U-Motion II PS+ Cup K132455 U-Motion II Acetabular System— K170089 Additional sizes… | 2013 |
| * | K170089 | U-Motion II Acetabular System— Additional sizesSummary page 4…Predicates U-Motion II PS+ Cup K132455 U-Motion II Acetabular System— K170089 Additional sizes United Orthopedic Corporation E-XPE Acetabular Components and U-… | 2017 |
| * | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular CupSummary page 4…089 Additional sizes United Orthopedic Corporation E-XPE Acetabular Components and U- K172833 Motion II Acetabular Cup U2 Hip System K111546 Osteonics® HA Gener… | 2018 |
| * | K111546 | U2 Hip SystemSummary page 4…lar Components and U- K172833 Motion II Acetabular Cup U2 Hip System K111546 Osteonics® HA Generation II Osteonics Corporation K983382 Acetabular Component Sysrem UOC-FDA-059… | 2011 |
| * | K983382 | Osteonics HA Generation II Acetabular Component SystemSummary page 4…tabular Cup U2 Hip System K111546 Osteonics® HA Generation II Osteonics Corporation K983382 Acetabular Component Sysrem UOC-FDA-059… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup System | 2026 | 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?
- The line of descent spans 27 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 58 of the 220 ancestors have a recall of any class.
- Of its descendants, K253948 (United Orthopedic Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K122185.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221149 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221149: U-Motion II Acetabular System-Extension line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221149
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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