510(k) · Cleared
ClearedUCP Stem
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 Mar 14, 2016 as substantially equivalent to K082239 (DePuy Orthopaedics, Inc., 2008) and 1 other predicate after a 193-day review. Its family tree reaches back 7 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 14, 2016
- Review
- 193 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935452 (1994). 28 ancestors in all, the oldest K802627 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 6 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 5 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- 4 generations backK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
- 3 generations backK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
- 2 generations backK042959 Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2004
- 1 generation backK082239 Depuy C-Stem AmtDePuy Orthopaedics, Inc. · 2008
- This deviceK152530 UCP StemUnited Orthopedic Corporation · 2016
- Descendant · cites it directly · 0 of its ownK250375 Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
- Descendant · cites it directly · 0 of its ownK191056 Conformity stem, cementedUnited Orthopedic Corporation · 2020
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 |
|---|---|---|---|---|---|
| −7 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −6 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −5 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −4 | K974331 | Uni-Rom Total Hip System Femoral Stem | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −3 | K001991 | Titan Porocoat Hip Prosthesis | DePuy Orthopaedics, Inc. | 2000 | — |
| −2 | K042959 | Depuy C-Stem Amt Hip Prosthesis | DePuy Orthopaedics, Inc. | 2004 | — |
| −1 | K082239 | Depuy C-Stem Amt | DePuy Orthopaedics, Inc. | 2008 | — |
| 0 (this device) | K152530 | UCP Stem | United Orthopedic Corporation | 2016 | — |
| +1 | K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025 | — |
| +1 | K191056 | Conformity stem, cemented | United Orthopedic Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K082239 | Depuy C-Stem AmtSummary page 4…Class II Classification Orthopedics Product Code LZO, JDI, LWJ, KWY Predicate Device 1. “DePuy” DePuy C-Stem AMT (K082239) 2. “Zimmer” CPT® 12/14 Hip Prostheses (K030265) Device Description: UCP (United Cement Polished) s… | 2008 |
| * | K030265 | CPT 12/14 Hip Prostheses, Model 00-8114-040/050-00Summary page 4…e LZO, JDI, LWJ, KWY Predicate Device 1. “DePuy” DePuy C-Stem AMT (K082239) 2. “Zimmer” CPT® 12/14 Hip Prostheses (K030265) Device Description: UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for thre… | 2003 |
What descends from it? (2)
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)
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 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K250375 (Waldemar Link GmbH & Co. KG, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K082239.
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. 2016, 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?
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. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is
unmanageable using other techniques.
4. Revision procedures where other treatments or devices have failed.
5. Patients suffering from disability due to previous fusion.
6. Patients with acute femoral neck fractures.
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/K152530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152530: UCP Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152530
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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