510(k) Report

510(k) · Cleared

Cleared

Patient Specific Acetabular Reconstruction Prosthesis

K092098510(k) TraditionalCleared Jan 22, 2010192-day reviewClass II21 CFR 888.3358

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

Smith & Nephew, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Jan 22, 2010 as substantially equivalent to K962541 (Smith & Nephew Richards, Inc., 1996) and 9 other predicates after a 192-day review. Its family tree reaches back 4 generations to 1986. 1 later device descends from it.

Decided
Jan 22, 2010
Review
192 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
10

Its longest line of descent runs back 4 generations to K861766 (1986). 17 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1996: 2 other ancestors1994: 1 other ancestor2000: 1 other ancestor1997: 1 other ancestor1992: 1 other ancestor1988: 1 other ancestor2013: 1 descendant clearedK861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 1986K964094 · Minifix · Ferguson Medical · 1996K061253 · Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2006K070756 · Smith and Nephew Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2007 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor 1 generation forward: 1 descendant K070756 · Smith and Nephew Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2007 · recalledK061253 · Reflection 3 Acetabular System · Smith & Nephew, Inc. · 2006K964094 · Minifix · Ferguson Medical · 1996K861766 · Howmedica Hoffmann Fixation Pin System · Howmedica Corp. · 19860
  1. Root · 4 generations backK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
  2. 3 generations backK964094 MinifixFerguson Medical · 1996
  3. 2 generations backK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
  4. 1 generation backK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
  5. This deviceK092098 Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc. · 2010
  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
−4K861766Howmedica Hoffmann Fixation Pin SystemHowmedica Corp.1986—
−3K964094MinifixFerguson Medical1996—
−2K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006—
−1K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.20076
0 (this device)K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.2010—
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199210
199410
199620
199710
199820
199910
200010
200310
200410
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K092098, 1986–2013Source: 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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 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? (10)

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
*K962541Reflection Acetabular Reinforcement Rings
Summary page 1
…Prosthesis is similar to the following commercially available devices regarding design features, overall indications, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301…
Smith & Nephew Richards, Inc.1996—
*K040680Contour HA Coated Reconstruction Ring
Summary page 1
…is is similar to the following commercially available devices regarding design features, overall indications, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * P…
Smith & Nephew, Inc.2004—
*K061253Reflection 3 Acetabular System
Summary page 1
…ly available devices regarding design features, overall indications, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Compone…
Smith & Nephew, Inc.2006—
*K070756Smith and Nephew Reflection 3 Acetabular System
Summary page 1
…ble devices regarding design features, overall indications, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K9830…
Smith & Nephew, Inc.20076
*K932755Reflection Acetabular Component
Summary page 1
…dications, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabul…
Smith & Nephew Richards, Inc.1994—
*K990666Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit…
Summary page 1
…, and materials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabular System…
Smith & Nephew, Inc.19991
*K060630Reflection 3-Hole Shell with Asymmetric Porous Coating
Summary page 1
…erials: * Contour Acetabular Rings 1K962541, K0406801 N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabular System (K973119…
Smith & Nephew, Inc.2006—
*K983035Custom Flanged Acetabular Component
Summary page 1
…N R3 Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabular System (K973119) DEPARTMENT OF HEALTH & HUMAN SERVICES…
Biomet, Inc.1998—
*K030861HA Pmi Flanged Acetabular Component
Summary page 1
…Acetabular System 1K061253, K0707561 * Reflection Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabular System (K973119) DEPARTMENT OF HEALTH & HUMAN SERVICES…
Biomet, Inc.2003—
*K973119Foundation Porous Acetabular System
Summary page 1
…on Acetabular System 1K932755, K990666, K0606301 * Patient Matched Flanged Acetabular Component 1K983035, K0308611 N Foundation Porous Acetabular System (K973119) DEPARTMENT OF HEALTH & HUMAN SERVICES…
Encore Orthopedics, Inc.1998—

Also cleared against K962541: 4 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 24 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • Of its descendants, K123598 (Smith & Nephew, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K962541.

How does its category compare?

All LPH devices

LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, 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
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

What is it indicated for?

The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application. The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows…

Read the full statement (99 words)

The Patient Specific Acetabular Reconstruction Prosthesis is intended to be used in primary and revision surgeries where the acetabulum has deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and/or protrusion as a result of the indications listed below. The device is for single use and is intended for cementless application.

The Patient Specific Acetabular Reconstruction Prosthesis is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endloprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip and diastrophic variant.

Indications for use as stated in the FDA summary.

Also cleared against K962541

4 other devices cite the same predicate.

  • K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc. · 20221 recall
  • K171073Smith & Nephew, Inc. REDAPT AugmentsSmith & Nephew, Inc. · 2017
  • K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. · 20132 recalls
  • K040680Contour HA Coated Reconstruction RingSmith & Nephew, Inc. · 2004

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 LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K092098 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092098: Patient Specific Acetabular Reconstruction Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092098

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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