510(k) · Cleared
ClearedPOLARSTEM Cemented Femoral Stem
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 Jul 22, 2021 as substantially equivalent to K130728 (Smith & Nephew, Inc., 2013) after a 269-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Jul 22, 2021
- Review
- 269 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932481 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 5 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 4 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 3 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 2 generations backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- 1 generation backK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
- This deviceK203175 POLARSTEM Cemented Femoral StemSmith & Nephew, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −5 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −4 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −3 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −2 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| −1 | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | Smith & Nephew, Inc. | 2013 | 1 |
| 0 (this device) | K203175 | POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HASummary page 4…Orthopaedics/87 Product Code: LZO Predicate Device: POLARSTEM Standard and Lateral Femoral Stems – K130728 The predicate devices have not been subject to a design related recal… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 3 other devices also cite its predicate K130728.
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. 2021, 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 POLARSTEM Cemented Femoral Stem is indicated for advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head; failure of previous hip surgery, such as joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The POLARSTEM Cemented Femoral Stem is intended for single use only and is to be implanted with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203175 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203175: POLARSTEM Cemented Femoral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203175
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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