510(k) Report

510(k) · Cleared

Cleared

Reflection Cross-Linked Uhmwpe Acetabular Components

K002747510(k) AbbreviatedCleared Dec 15, 2000101-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 Dec 15, 2000 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 129 later devices descend from it.

Decided
Dec 15, 2000
Review
101 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

129 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2012: 10 descendants cleared2022: 10 descendants cleared2011: 9 descendants cleared2013: 10 descendants cleared2006: 2 descendants cleared2001: 1 descendant cleared2016: 5 descendants cleared2015: 6 descendants cleared2007: 1 descendant cleared2010: 6 descendants cleared2009: 1 descendant cleared2020: 2 descendants cleared2018: 7 descendants cleared2024: 7 descendants cleared2017: 11 descendants cleared2026: 9 descendants cleared2025: 9 descendants cleared2023: 7 descendants cleared2019: 7 descendants cleared2014: 5 descendants cleared2021: 4 descendants cleared200020052010201520202025
  1. This deviceK002747 Reflection Cross-Linked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc. · 2000
  2. Descendant · cites it directly · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
  3. Descendant · 2 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
  5. Descendant · 2 generations on · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
  6. Descendant · 3 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

2001: 12006: 22007: 12009: 12010: 62011: 92012: 102013: 102014: 52015: 62016: 52017: 112018: 72019: 72020: 22021: 42022: 102023: 72024: 72025: 92026: 9
2001high 11 (2017) · low 0 (2002)2026

Most influential descendants

Showing 5 of 129 · See all
  • K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · cites it directly120descendants
  • K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 2 generations on91descendants
  • K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · 2 generations on46descendants
  • K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · 2 generations on35descendants
  • K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 3 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002747Reflection Cross-Linked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc.2000—
+1K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006—
+2K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.20076
+2K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc.2009—
+2K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc.2010—
+3K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200620
200710
200910
201060
201190
2012100
2013100
201450
201560
201650
2017110
201870
201970
202020
202140
2022100
202370
202470
202590
202690
FIG. 1 — Lineage of K002747, 2000–2026Source: 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), 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 24.2 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006120
K061066Synergy Hip SystemSmith & Nephew, Inc.200616
K150790REDAPT Porous Acetabular Shell and Cemented LinerSmith & Nephew, Inc.201513
K113848R3 Xlpe LinersSmith & Nephew, Inc.20127
K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc.20164
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K013658Modification to Reflection Cross-Linked Uhmwpe Acetabular ComponentsSmith & Nephew, Inc.20013
K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162
K211330R3 Large Head LinersSmith & Nephew, Inc.20220
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?

  • Of its descendants, K061253 (Smith & Nephew, Inc., 2006) has gone furthest, with 120 descendants of its own.

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.

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—

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692 FDA decisions under this applicant name. See the company

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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/K002747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002747: Reflection Cross-Linked Uhmwpe Acetabular Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002747

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026