510(k) · Cleared
Recalled · Class II · 2017Polarstem Standard and Lateral Femoral Stems with TI/HA
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 Oct 10, 2013 as substantially equivalent to K120211 (Smith & Nephew, Inc., 2012) and 2 other predicates after a 206-day review. Its family tree reaches back 5 generations to 1994. 11 later devices descend from it. It has been recalled once.
- Decided
- Oct 10, 2013
- Review
- 206 days
- Class
- Class II
- Product code
- LZO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K932481 (1994). 7 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 4 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 3 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 2 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 1 generation backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- This deviceK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013
- Descendant · cites it directly · 7 of its ownK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK240381 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK160011 H-Max S stemLima Corporate S.P.A. · 2016
- Descendant · 3 generations on · 0 of its ownK250571 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc. · 2015 · cites it directly7descendants
- K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
- K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024 · 2 generations on1descendant
- K160011H-Max S stemLima Corporate S.P.A. · 2016 · cites it directly1descendant
- K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −4 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −3 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −2 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −1 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| 0 (this device) | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | Smith & Nephew, Inc. | 2013 | — |
| +1 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | 2015 | 1 |
| +1 | K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022 | 1 |
| +2 | K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2024 | — |
| +1 | K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016 | — |
| +3 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSummary page 1…, LWJ, MEH Device Description The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLLJS Standard and Lateral Femoral Stems with Ti/HA cleared via K1 2021 1 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6A1-4V with a double co… | 2012 |
| * | K052792 | Anthology Hip StemSummary page 1…dard and Lateral Stems with Ti/HA are similar to the SL-PLLJS Standard and Lateral Femoral Stems with Ti/HA cleared via K1 2021 1 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6A1-4V with a double coating (triple layer): titanium plasma sprayed co… | 2005 |
| * | K953111 | CorailSummary page 2…w, Inc. ANTHOLOGY Hip Stems K052792 10/07/2005 Landlos, Inc. CORAIL Hip Stems K9531 11 12/27/1996 The following mechanical tests were used as a basis for the determination of substantial equivalence: *… | 1996 |
What descends from it? (11)
See all 114 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-3100-2017 | Device Design | The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K143739 (Smith & Nephew, Inc., 2015) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K120211.
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. 2013, 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 Standard and Lateral Femoral Stems with Ti/HA are 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: joint reconstruction, internal fixation, arthrodesls. hemiarthropiasty, surface replacement arlhroplasty. or total hip replacement
"All forms of osteoarthritis
"Patients with hips at risk of dislocation
* Femoral neck fracture or proximal fracture to hip joint
The POLARSTEM Standard and Lateral Femoral Stem with TI/HA is intended for single use only and isto be Implanted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130728: Polarstem Standard and Lateral Femoral Stems with TI/HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130728
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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