510(k) Report

510(k) · Cleared

Cleared

P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component

K935452510(k) TraditionalCleared Oct 6, 1994328-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

Johnson & Johnson Orthopaedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Oct 6, 1994 after a 328-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 213 later devices descend from it.

Decided
Oct 6, 1994
Review
328 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
0

213 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1998: 2 descendants cleared2000: 2 descendants cleared2017: 13 descendants cleared2020: 15 descendants cleared2004: 4 descendants cleared2005: 3 descendants cleared2024: 17 descendants cleared2021: 9 descendants cleared2001: 1 descendant cleared2018: 12 descendants cleared2007: 1 descendant cleared2006: 1 descendant cleared2011: 5 descendants cleared2015: 6 descendants cleared2010: 3 descendants cleared2013: 12 descendants cleared2008: 3 descendants cleared2023: 20 descendants cleared2022: 16 descendants cleared2016: 9 descendants cleared2019: 14 descendants cleared2012: 8 descendants cleared2025: 18 descendants cleared2026: 14 descendants cleared2014: 3 descendants cleared1990200020102020
  1. This deviceK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
  2. Descendant · cites it directly · 212 of its ownK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
  3. Descendant · 2 generations on · 210 of its ownK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
  4. Descendant · cites it directly · 189 of its ownK974331 Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998
  5. Descendant · 2 generations on · 188 of its ownK001991 Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000
  6. Descendant · 3 generations on · 168 of its ownK042992 Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · Recalled

Showing 5 of 213 descendants. See all descendants

Descendants cleared per year

1996: 21998: 22000: 22001: 12004: 42005: 32006: 12007: 12008: 32010: 32011: 52012: 82013: 122014: 32015: 62016: 92017: 132018: 122019: 142020: 152021: 92022: 162023: 202024: 172025: 182026: 14
1996high 20 (2023) · low 0 (1997)2026

Most influential descendants

Showing 5 of 213 · See all
  • K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996 · cites it directly212descendants
  • K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996 · 2 generations on210descendants
  • K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc. · 1998 · cites it directly189descendants
  • K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc. · 2000 · 2 generations on188descendants
  • K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc. · 2005 · 3 generations on168descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935452P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc.1994—
+1K945518P.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—
+1K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998—
+2K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000—
+3K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199820
200020
200110
200440
200530
200610
200710
200830
201030
201150
201280
2013120
201430
201560
201690
2017130
2018120
2019140
2020150
202190
2022160
2023200
2024170
2025180
2026140
FIG. 1 — Lineage of K935452, 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 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
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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? (213)

See all 213

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

NumberDeviceApplicantDecidedDescendants
K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc.1996212
K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189

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, K945518 (Johnson & Johnson Professionals, Inc., 1996) has gone furthest, with 212 descendants of its own.

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—

More from Johnson & Johnson Orthopaedics, Inc.

22 FDA decisions under this applicant name. See the company

  • K931466PFC Modular Total Knee System, Porous Coated SacriJohnson & Johnson Orthopaedics, Inc. · 1994
  • K940190Ultima Unipolar Modular HeadJohnson & Johnson Orthopaedics, Inc. · 1994
  • K933275P.F.C. Ceramic Hip HeadJohnson & Johnson Orthopaedics, Inc. · 1994
  • K932595Orthosorb (TM) Absorbable Cement RestrictorJohnson & Johnson Orthopaedics, Inc. · 1994
  • K931655P.F.C. Bipolar Hip SystemJohnson & Johnson Orthopaedics, Inc. · 1994

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/K935452 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935452: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935452

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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