510(k) Report

510(k) · Cleared

Cleared

Reflection Acetabular Component

K932755510(k) TraditionalCleared May 6, 1994350-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 Richards, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on May 6, 1994 after a 350-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 246 later devices descend from it.

Decided
May 6, 1994
Review
350 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
0

246 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2022: 16 descendants cleared2010: 11 descendants cleared2017: 16 descendants cleared2013: 12 descendants cleared2006: 2 descendants cleared2016: 9 descendants cleared1999: 1 descendant cleared2012: 16 descendants cleared2007: 3 descendants cleared2009: 2 descendants cleared2020: 8 descendants cleared2024: 16 descendants cleared2025: 22 descendants cleared2026: 16 descendants cleared2023: 17 descendants cleared2018: 13 descendants cleared2021: 9 descendants cleared2019: 18 descendants cleared2004: 4 descendants cleared2011: 8 descendants cleared2014: 13 descendants cleared2005: 2 descendants cleared2008: 1 descendant cleared2015: 11 descendants cleared1990200020102020
  1. This deviceK932755 Reflection Acetabular ComponentSmith & Nephew Richards, Inc. · 1994
  2. Descendant · cites it directly · 161 of its ownK993082 Exactech Acumatch Integrated Hip System a-Series Porous Coated…Exactech, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 145 of its ownK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
  4. Descendant · cites it directly · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
  5. Descendant · 2 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 64 of its ownK042842 Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004

Showing 5 of 246 descendants. See all descendants

Descendants cleared per year

1999: 12004: 42005: 22006: 22007: 32008: 12009: 22010: 112011: 82012: 162013: 122014: 132015: 112016: 92017: 162018: 132019: 182020: 82021: 92022: 162023: 172024: 162025: 222026: 16
1999high 22 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 246 · See all
  • K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc. · 1999 · cites it directly161descendants
  • K041906Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · 2 generations on145descendants
  • K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · cites it directly120descendants
  • K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 2 generations on91descendants
  • K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc. · 2004 · 3 generations on64descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932755Reflection Acetabular ComponentSmith & Nephew Richards, Inc.1994—
+1K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular…Exactech, Inc.19992
+2K041906Exactech 12/14 Total Hip SystemExactech, Inc.20041
+1K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006—
+2K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc.20076
+3K042842Novation 12/14 Press-Fit Femoral StemExactech, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200440
200520
200620
200730
200810
200920
2010110
201180
2012160
2013120
2014130
2015110
201690
2017160
2018130
2019180
202080
202190
2022160
2023170
2024160
2025220
2026160
FIG. 1 — Lineage of K932755, 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), 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
Get a 510(k) Report

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? (246)

See all 246

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

NumberDeviceApplicantDecidedDescendants
K993082Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular ComponentExactech, Inc.1999161
K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc.2006120
K163577Ecofit® Hip SystemImplantcast GmbH20179
K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223
K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.20223
K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162
K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171
K092098Patient Specific Acetabular Reconstruction ProsthesisSmith & Nephew, Inc.20101
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, K993082 (Exactech, Inc., 1999) has gone furthest, with 161 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—

More from Smith & Nephew Richards, Inc.

93 FDA decisions under this applicant name. See the company

  • P810020/S005OsteopalSmith & Nephew Richards, Inc. · 1998
  • P810020/S004Palacos E-Flow (Osteopal) Bone CementSmith & Nephew Richards, Inc. · 1998
  • K965224Empower Anterior Direct ScrewsSmith & Nephew Richards, Inc. · 1997
  • K963509Global Taper Tapered Hip System, GT SpectronSmith & Nephew Richards, Inc. · 1997
  • K960444Finn Rod to Rod ConnectorSmith & Nephew Richards, Inc. · 1997

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/K932755 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932755: Reflection Acetabular Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932755

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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