510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA

K143739510(k) TraditionalCleared Apr 20, 2015111-day reviewClass II21 CFR 888.3353Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 20, 2015 as substantially equivalent to K130728 (Smith & Nephew, Inc., 2013) after a 111-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it. It has been recalled once.

Decided
Apr 20, 2015
Review
111 days
Class
Class II
Product code
LZO
Recalls
1
Predicates
1

Its longest line of descent runs back 6 generations to K932481 (1994). 8 ancestors in all. 7 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1996: 1 other ancestor2021: 1 descendant cleared2022: 1 descendant cleared2024: 3 descendants cleared2023: 1 descendant cleared2025: 1 descendant clearedK932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 2002K072852 · SL-Plus Standard and Lateral Hip Stems · Smith & Nephew, Inc. · 2008K120211 · SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating · Smith & Nephew, Inc. · 2012K130728 · Polarstem Standard and Lateral Femoral Stems with TI/HA · Smith & Nephew, Inc. · 2013 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants K130728 · Polarstem Standard and Lateral Femoral Stems with TI/HA · Smith & Nephew, Inc. · 2013 · recalledK120211 · SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating · Smith & Nephew, Inc. · 2012K072852 · SL-Plus Standard and Lateral Hip Stems · Smith & Nephew, Inc. · 2008K021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 2002K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994−50
  1. Root · 6 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
  2. 5 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
  3. 4 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
  4. 3 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
  5. 2 generations backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
  6. 1 generation backK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
  7. This deviceK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015
  8. Descendant · cites it directly · 3 of its ownK211176 Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · Recalled
  9. Descendant · cites it directly · 1 of its ownK240381 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024
  10. Descendant · 2 generations on · 0 of its ownK250571 CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025
  11. Descendant · 2 generations on · 0 of its ownK240783 Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular…Smith & Nephew, Inc. · 2024
  12. Descendant · 2 generations on · 0 of its ownK242375 OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2021: 12022: 12023: 12024: 32025: 1
2021high 3 (2024) · low 0 (2026)2026

Most influential descendants

Showing 5 of 7 · See all
  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 2022 · cites it directly3descendants
  • K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2024 · cites it directly1descendant
  • K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc. · 2025 · 2 generations on0descendants
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc. · 2024 · 2 generations on0descendants
  • K242375OR3O Dual Mobility SystemSmith & Nephew, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K932481SL-Plus and SLR-PlusEncore Orthopedics, Inc.1994—
−5K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000—
−4K021178SL-Plus Lateralized StemPlus Orthopedics2002—
−3K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc.2008—
−2K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc.2012—
−1K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.20131
0 (this device)K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.2015—
+1K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20221
+1K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.2024—
+2K250571CATALYSTEM Femoral StemsSmith & Nephew, Inc.2025—
+2K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners…Smith & Nephew, Inc.2024—
+2K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202210
202310
202430
202510
FIG. 1 — Lineage of K143739, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K130728Polarstem Standard and Lateral Femoral Stems with TI/HA
Summary page 4
…tability, and a 12/14 taper. The collared and valgus femoral stems are substantially equivalent to the POLARSTEM standard and lateral femoral stem with Ti/HA cleared via K130728. Intended Use The POLARSTEM Collared (Standard and Lateral) and Valgus Stem with Ti/HA (INTEGRATION- PLUS™) is indicated for:…
Smith & Nephew, Inc.20131

Also cleared against K130728: 3 other devices →

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.20241
K211548POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.20210

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 22, 2020Class IIZ-2827-2020Device DesignMultiple lots being recalled due to a product design issue

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K211176 (Smith & Nephew, Inc., 2022) has gone furthest, with 3 descendants of its own.
  • 3 other devices also cite its predicate K130728.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LZO

14in 2025

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The POLARSTEM Collared and Valgus Stem with Ti/HA (INTEGRATION-PLUS™) 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: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K130728

3 other devices cite the same predicate.

  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K203175POLARSTEM Cemented Femoral StemSmith & Nephew, Inc. · 2021
  • K160011H-Max S stemLima Corporate S.P.A. · 2016

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

Recent decisions in LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K143739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143739: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143739

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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