510(k) Report

510(k) · Cleared

Cleared

Smith & Nephew Platform Hip Stem

K052275510(k) AbbreviatedCleared Dec 7, 2005107-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 Dec 7, 2005 as substantially equivalent to K001942 (Plus Orthopedics, 2000) and 5 other predicates after a 107-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.

Decided
Dec 7, 2005
Review
107 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K935452 (1994). 19 ancestors in all, the oldest K851422 (1985). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestors1994: 3 other ancestors1992: 2 other ancestors1991: 1 other ancestor1987: 1 other ancestor1985: 1 other ancestor2013: 1 descendant clearedK935452 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Orthopaedics, Inc. · 1994K945518 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Professionals, Inc. · 1996K961939 · S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) · Johnson & Johnson Professionals, Inc. · 1996K042127 · Smith & Nephew Modular Hip · Smith & Nephew, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors 1 generation forward: 1 descendant K042127 · Smith & Nephew Modular Hip · Smith & Nephew, Inc. · 2004K961939 · S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) · Johnson & Johnson Professionals, Inc. · 1996K945518 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Professionals, Inc. · 1996K935452 · P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component · Johnson & Johnson Orthopaedics, Inc. · 19940
  1. Root · 4 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
  2. 3 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
  3. 2 generations backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
  4. 1 generation backK042127 Smith & Nephew Modular HipSmith & Nephew, Inc. · 2004
  5. This deviceK052275 Smith & Nephew Platform Hip StemSmith & Nephew, Inc. · 2005
  6. Descendant · cites it directly · 0 of its ownK123598 Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K935452P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc.1994—
−3K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc.1996—
−2K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996—
−1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.2004—
0 (this device)K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.2005—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
199110
199220
199430
199620
199710
199910
200020
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K052275, 1994–2013Source: 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? (6)

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
…ition to the following predicate devices - Orthopedics Alloclassic Plus/SLR-Plus Femoral Hip Sterns (K001942), Centerpulse Smith & Nephew Modular Hip Zweymuller SL/SLL Femora…
Plus Orthopedics2000—
*K030373Alloclassic Zweymueller SL/SLL Femoral Stem
Summary page 2
…emoral Hip Sterns (K001942), Centerpulse Smith & Nephew Modular Hip Zweymuller SL/SLL Femoral Ilip Stems (K030373), System (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip a…
Centerpulse Orthopedics, Inc.20031
*K042127Smith & Nephew Modular Hip
Summary page 2
…Smith & Nephew Modular Hip Zweymuller SL/SLL Femoral Ilip Stems (K030373), System (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip and K002996).…
Smith & Nephew, Inc.2004—
*K963509Global Taper Tapered Hip System, GT Spectron
Summary page 2
…Smith & Nephew Modular Hip Zweymuller SL/SLL Femoral Ilip Stems (K030373), System (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip and K002996).…
Smith & Nephew Richards, Inc.1997—
*K991485Synergy Porous Size 8 Hip Stem
Summary page 2
…Smith & Nephew Modular Hip Zweymuller SL/SLL Femoral Ilip Stems (K030373), System (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip and K002996).…
Smith & Nephew, Inc.1999—
*K002996Synergy HA Coated Porous Femoral Stems
Summary page 2
…er SL/SLL Femoral Ilip Stems (K030373), System (K963509, K991485, Stem (K042127) and the Smith & Nephew Synergy Hip and K002996). Public Health Service DEPA…
Smith & Nephew, Inc.2000—

Also cleared against K001942: 8 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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 11 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
  • 1 of the 19 ancestors has a recall of any class.
  • Of its descendants, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 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.

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?

Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease INIDJDI or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip…

Read the full statement (122 words)

Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease INIDJDI or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity Smith & Nephew Platform Hip Stem components are for single use only.

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
  • K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
  • 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
  • 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/K052275 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052275: Smith & Nephew Platform Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052275

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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