510(k) · Cleared
ClearedLocking Cage, Full XPE Cup
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 Aug 25, 2017 as substantially equivalent to K980774 (Osteonics Corp., 1998) and 3 other predicates after a 260-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.
- Decided
- Aug 25, 2017
- Review
- 260 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K955033 (1996). 193 ancestors in all, the oldest K810258 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 7 generations between
- 3 generations backK083312 Minihip StemCorin USA · 2010
- 2 generations backK103518 Trinity Acetabular SystemCorin USA · 2011
- 1 generation backK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- This deviceK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · cites it directly · 2 of its ownK172833 E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK221149 U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023
- Descendant · 3 generations on · 0 of its ownK253948 Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
Show all 11 generations
- Root · 11 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 10 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 9 generations backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- 8 generations backK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- 7 generations backK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- 6 generations backK043079 Bicontact Hip System with U-CapAesculap · 2004
- 5 generations backK060437 Excia Total Hip System with U-CapAesculap, Inc. · 2006
- 4 generations backK080584 Metha Short Stem Hip SystemAesculap Implant System, Inc. · 2008
- 3 generations backK083312 Minihip StemCorin USA · 2010
- 2 generations backK103518 Trinity Acetabular SystemCorin USA · 2011
- 1 generation backK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- This deviceK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation · 2018 · cites it directly2descendants
- K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation · 2023 · 2 generations on1descendant
- K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −10 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −9 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| −8 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| −7 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| −6 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| −5 | K060437 | Excia Total Hip System with U-Cap | Aesculap, Inc. | 2006 | — |
| −4 | K080584 | Metha Short Stem Hip System | Aesculap Implant System, Inc. | 2008 | — |
| −3 | K083312 | Minihip Stem | Corin USA | 2010 | — |
| −2 | K103518 | Trinity Acetabular System | Corin USA | 2011 | — |
| −1 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| 0 (this device) | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +1 | K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | United Orthopedic Corporation | 2018 | — |
| +2 | K221149 | U-Motion II Acetabular System-Extension line | United Orthopedic Corporation | 2023 | — |
| +3 | 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 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 18 | 0 |
| 1995 | 16 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 10 | 0 |
| 1999 | 9 | 0 |
| 2000 | 17 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 9 | 0 |
| 2004 | 3 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K980774 | Osteonics Gap-II Restoration Acetabular ShellsSummary page 4…Orthopaedics Product Code LZO, JDI Predicate Device 1. “Stryker Howmedica Osteonics” GAP-II Restoration Acetabular Shells (K980774) 2. “Smith & Nephew” Cemented all polyethylene Acetabular component (K991026)… | 1998 |
| * | K991026 | Reflection Crosslinked Uhmwpe Acetabular ComponentsSummary page 4…Acetabular Shells (K980774) 2. “Smith & Nephew” Cemented all polyethylene Acetabular component (K991026) 3. “United” U-Motion II Acetabular Component (K122185) UOC-FDA-048… | 1999 |
| * | K122185 | U-Motion II Acetabular SystemSummary page 4…mith & Nephew” Cemented all polyethylene Acetabular component (K991026) 3. “United” U-Motion II Acetabular Component (K122185) UOC-FDA-048 Page: 7-1/4… | 2013 |
| * | K021911 | Trident Crossfire Polyuethylene LinersSummary page 5…510(k) Summary 4. “Howmedica” Trident® Crossfire® Polyethylene Liners (K021911) Device Description: “United” Locking Cage The “United” Locking Cage is designed to achieve stable and lasting fixation of th… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172833 | E-XPE Acetabular Components and U-Motion II Acetabular Cup | 2018 | 2 |
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 21 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 49 of the 192 ancestors have a recall of any class.
- Of its descendants, K172833 (United Orthopedic Corporation, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K980774.
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. 2017, 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?
For Locking Cage 1. Revision of previous unsuccessful acetabular replacement. 2. Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures. For Full XPE Cup 1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia; 2. Inflammatory degenerative joint…
Read the full statement (113 words)
For Locking Cage
1. Revision of previous unsuccessful acetabular replacement.
2. Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.
For Full XPE 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/K163441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163441: Locking Cage, Full XPE Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163441
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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