510(k) · Cleared
ClearedCATALYSTEM Femoral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jun 27, 2024 as substantially equivalent to K143739 (Smith & Nephew, Inc., 2015) and 1 other predicate after a 140-day review. Its family tree reaches back 7 generations to 1994. 1 later device descends from it.
- Decided
- Jun 27, 2024
- Review
- 140 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K932481 (1994). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 6 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 5 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 4 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 3 generations backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- 2 generations backK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
- 1 generation backK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK240381 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250571 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −6 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −5 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −4 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −3 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| −2 | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | Smith & Nephew, Inc. | 2013 | 1 |
| −1 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | 2015 | 1 |
| 0 (this device) | K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024 | — |
| +1 | K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASummary page 5…ly equivalentto that of the predicate Smith & Nephew systems cleared under the premarket notifications ANTHOLOGY Hip Stems (K052792, 10/07/2005) and POLARSTEM Hip Stems (K143739, 04/20/2015). The indications for use of the subject device were updated to clarify the type of hip arthroplasty they are indicat… | 2015 |
| * | K052792 | Anthology Hip StemSummary page 5…r the CATALYSTEM Femoral Stems are substantially equivalentto that of the predicate Smith & Nephew systems cleared under the premarket notifications ANTHOLOGY Hip Stems (K052792, 10/07/2005) and POLARSTEM Hip Stems (K143739, 04/20/2015). The indications for use of the subject device were updated to clarify… | 2005 |
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 |
|---|---|---|---|
| K250571 | CATALYSTEM Femoral Stems | 2025 | 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 30 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K250571 (Smith & Nephew, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K143739.
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. 2024, 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 CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications: Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also…
Read the full statement (110 words)
The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:
Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.
The CATALYSTEM Femoral Stems are intended for use without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240381: CATALYSTEM Femoral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240381
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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