510(k) Report

510(k) · Cleared

Cleared

SL-Plus Standard and Lateral Hip Stems

K072852510(k) TraditionalCleared Jun 9, 2008249-day reviewClass II21 CFR 888.3353

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 Jun 9, 2008 as substantially equivalent to K001942 (Plus Orthopedics, 2000) and 1 other predicate after a 249-day review. Its family tree reaches back 3 generations to 1994. 27 later devices descend from it.

Decided
Jun 9, 2008
Review
249 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K932481 (1994). 27 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared2012: 3 descendants cleared2013: 2 descendants cleared2014: 1 descendant cleared2017: 1 descendant cleared2010: 1 descendant cleared2015: 3 descendants cleared2020: 2 descendants cleared2025: 2 descendants cleared2024: 3 descendants cleared2023: 2 descendants cleared2019: 1 descendant cleared2021: 3 descendants cleared2016: 1 descendant cleared2026: 1 descendant clearedReference device: K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 1994K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 20021990200020102020
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K021178 · SL-Plus Lateralized Stem · Plus Orthopedics · 2002K001942 · SL-Plus and SLR-Plus Stems · Plus Orthopedics · 2000K932481 · SL-Plus and SLR-Plus · Encore Orthopedics, Inc. · 19940+5
  1. Root · 3 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
  2. 2 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
  3. 1 generation backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
  4. This deviceK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
  5. Descendant · cites it directly · 18 of its ownK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
  6. Descendant · 2 generations on · 11 of its ownK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
  7. Descendant · 2 generations on · 8 of its ownK122296 SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012
  8. Descendant · 3 generations on · 7 of its ownK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015 · Recalled
  9. Descendant · cites it directly · 5 of its ownK133370 Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve…Signature Orthopaedics Pty Limited · 2014

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2010: 12012: 32013: 22014: 12015: 32016: 12017: 12019: 12020: 22021: 32022: 12023: 22024: 32025: 22026: 1
2010high 3 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 27 · See all
  • K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012 · cites it directly18descendants
  • K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · 2 generations on11descendants
  • K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc. · 2012 · 2 generations on8descendants
  • K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc. · 2015 · 3 generations on7descendants
  • K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited · 2014 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K932481SL-Plus and SLR-PlusEncore Orthopedics, Inc.1994—
−2K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000—
−1K021178SL-Plus Lateralized StemPlus Orthopedics2002—
0 (this device)K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc.2008—
+1K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc.2012—
+2K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.20131
+2K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc.2012—
+3K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.20151
+1K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip…Signature Orthopaedics Pty Limited2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201230
201320
201410
201530
201610
201710
201910
202020
202130
202210
202320
202430
202520
202610
FIG. 1 — Lineage of K072852, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K001942SL-Plus and SLR-Plus Stems
Summary page 1
…is premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively. Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactu…
Plus Orthopedics2000—
*K021178SL-Plus Lateralized Stem
Summary page 1
…fication is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively. Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-…
Plus Orthopedics2002—
†K932481SL-Plus and SLR-PlusEncore Orthopedics, Inc.1994—

Also cleared against K001942: 8 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc.201218
K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145
K093991SLR-Plus Standard and Lateral Femoral StemsSmith & Nephew, Inc.20105
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K170473C2 femoral stemLima Corporate S.P.A.20170
K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20130

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 14 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K120211 (Smith & Nephew, Inc., 2012) has gone furthest, with 18 descendants of its own.
  • 8 other devices also cite its predicate K001942.

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. 2008, 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 SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateratized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Indications for use as stated in the FDA summary.

Also cleared against K001942

8 other devices cite the same predicate.

  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 20132 recalls
  • K093991SLR-Plus Standard and Lateral Femoral StemsSmith & Nephew, Inc. · 2010
  • K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A. · 20081 recall
  • K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc. · 20061 recall
  • K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc. · 2005
  • K041950Apex K2 Hip SystemApex Surgical, LLC · 20041 recall

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/K072852 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072852: SL-Plus Standard and Lateral Hip Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072852

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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