510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Hard Tissue Replace (HTR (R))-Patient-Match Implant

K924935510(k) TraditionalCleared Sep 2, 1993337-day reviewClass II21 CFR 878.3500Recalls 1

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

Polyclinic Medical Center · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Cleared on Sep 2, 1993 after a 337-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it. It has been recalled once.

Decided
Sep 2, 1993
Review
337 days
Class
Class II
Product code
KKY
Recalls
1
Predicates
0

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

Descendants, by year cleared 2014: 2 descendants cleared2005: 2 descendants cleared2007: 2 descendants cleared2010: 1 descendant cleared2016: 4 descendants cleared2006: 1 descendant cleared2011: 3 descendants cleared2018: 2 descendants cleared2013: 2 descendants cleared2012: 4 descendants cleared2015: 3 descendants cleared2025: 3 descendants cleared2026: 6 descendants cleared2017: 1 descendant cleared2019: 5 descendants cleared2022: 3 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK924935 Hard Tissue Replace (HTR (R))-Patient-Match ImplantPolyclinic Medical Center · 1993
  2. Descendant · cites it directly · 50 of its ownK043250 Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · Recalled
  3. Descendant · 2 generations on · 23 of its ownK103010 Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · Recalled
  4. Descendant · 3 generations on · 20 of its ownK111065 Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011
  5. Descendant · 2 generations on · 20 of its ownK072601 Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007
  6. Descendant · 2 generations on · 18 of its ownK052871 Stryker Custom TI ImplantStryker Leibinger · 2005

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 22010: 12011: 32012: 42013: 22014: 22015: 32016: 42017: 12018: 22019: 52020: 32021: 22022: 32023: 12024: 12025: 32026: 6
2005high 6 (2026) · low 0 (2008)2026

Most influential descendants

Showing 5 of 51 · See all
  • K043250Stryker Patient Specific Polymer ImplantStryker Leibinger · 2005 · cites it directly50descendants
  • K103010Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2010 · 2 generations on23descendants
  • K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics · 2011 · 3 generations on20descendants
  • K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC · 2007 · 2 generations on20descendants
  • K052871Stryker Custom TI ImplantStryker Leibinger · 2005 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924935Hard Tissue Replace (HTR (R))-Patient-Match ImplantPolyclinic Medical Center1993—
+1K043250Stryker Patient Specific Polymer ImplantStryker Leibinger20054
+2K103010Stryker Patient Specific Polymer ImplantHowmedica Osteonics Corp., Dba Stryker Orthopaedics20101
+3K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics2011—
+2K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC2007—
+2K052871Stryker Custom TI ImplantStryker Leibinger2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200720
201010
201130
201240
201320
201420
201530
201640
201710
201820
201950
202030
202120
202230
202310
202410
202530
202660
FIG. 1 — Lineage of K924935, 1993–2026Source: 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 KKY? 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 KKY device

  1. #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
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? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K043250Stryker Patient Specific Polymer ImplantStryker Leibinger200550
K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 13, 2016Class IIZ-2751-2016PackagingPotential sterility deficiency.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K043250 (Stryker Leibinger, 2005) has gone furthest, with 50 descendants of its own.

How does its category compare?

All KKY devices

KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KKY

1in 2021

2007: 12008: 12010: 12011: 12013: 12014: 32015: 12016: 22021: 1
2007high 3 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KKY

224in 2014

2014: 224 days median
2007high 224 (2014)2026

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

Recalls per year · KKY

1in 2013

2008: 42013: 1
2007high 4 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KKY

1in 2025

2008: 32009: 92010: 52011: 132012: 222013: 172014: 92015: 182016: 252017: 192018: 172019: 202020: 132021: 122022: 12023: 32024: 12025: 1
2007high 25 (2016) · low 0 (2007)2025

MAUDE reports naming product code KKY, 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
20071—00
20081—43
20090—09
20101—05
20111—013
20120—022
20131—117
2014322409
20151—018
20162—025
20170—019
20180—017
20190—020
20200—013
20211—012
20220—01
20230—03
20240—01
20250—01
20260—0—

More from Polyclinic Medical Center

2 FDA decisions under this applicant name. See the company

  • K833332Schultz EndholdPolyclinic Medical Center · 1983

Recent decisions in KKY

The KKY category page

  • K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC · 2021
  • K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc. · 2016
  • K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc. · 2016
  • K141880Biopor Aoc Porous Polyethylene, CereporCeremed, Inc. · 2015
  • K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials · 2014

https://510kreport.com/device/K924935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924935: Hard Tissue Replace (HTR (R))-Patient-Match Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924935

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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