510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Medpor Surg Implant Material:Prefor Cran/Fac Impla

K922489510(k) TraditionalCleared Sep 2, 199298-day reviewClass II21 CFR 878.3550Recalls 1

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

Porex Technologies Corp. · FWP Prosthesis, Chin, Internal

Cleared on Sep 2, 1992 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 133 devices in its family, counting itself, have a Class I recall. 132 later devices descend from it. It has been recalled once.

Decided
Sep 2, 1992
Review
98 days
Class
Class II
Product code
FWP
Recalls
1
Predicates
0

132 later devices descend from it, 9 citing it directly. 2 of the 133 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1996: 1 descendant cleared2005: 4 descendants cleared2016: 8 descendants cleared2002: 3 descendants cleared2009: 3 descendants cleared2010: 3 descendants cleared1997: 1 descendant cleared2013: 5 descendants cleared2014: 9 descendants cleared2007: 4 descendants cleared2019: 7 descendants cleared2008: 4 descendants cleared2006: 5 descendants cleared2017: 3 descendants cleared2011: 9 descendants cleared, 2 with a Class I recall22012: 6 descendants cleared2021: 4 descendants cleared1998: 1 descendant cleared1999: 2 descendants cleared2015: 5 descendants cleared2003: 2 descendants cleared2023: 11 descendants cleared2020: 4 descendants cleared2004: 1 descendant cleared2024: 7 descendants cleared2022: 5 descendants cleared2025: 1 descendant cleared2026: 11 descendants cleared2018: 3 descendants cleared1990200020102020
  1. This deviceK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992
  2. Descendant · cites it directly · 50 of its ownK970400 Bone Source HydroxyapatiteOrthofix, Inc. · 1997
  3. Descendant · 2 generations on · 49 of its ownK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
  4. Descendant · cites it directly · 46 of its ownK022665 Porous Hdpe Surgical Implants, to BE Distributed Under Various…Hohenstein Enterprises, Inc. · 2002
  5. Descendant · 2 generations on · 45 of its ownK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
  6. Descendant · cites it directly · 43 of its ownK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005

Showing 5 of 132 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 11999: 22002: 32003: 22004: 12005: 42006: 52007: 42008: 42009: 32010: 32011: 92012: 62013: 52014: 92015: 52016: 82017: 32018: 32019: 72020: 42021: 42022: 52023: 112024: 72025: 12026: 11
1996high 11 (2023) · low 0 (2000)2026

Class I recalls in this family

  • K103822 Synthes Hemostatic Bone Putty (HBP)5 generations on · 2011
  • K113079 Synthes Hemostatic Bone Putty5 generations on · 2011

Most influential descendants

Showing 5 of 132 · See all
  • K970400Bone Source HydroxyapatiteOrthofix, Inc. · 1997 · cites it directly50descendants
  • K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp. · 1998 · 2 generations on49descendants
  • K022665Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including…Hohenstein Enterprises, Inc. · 2002 · cites it directly46descendants
  • K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999 · 2 generations on45descendants
  • K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc. · 2005 · cites it directly43descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922489Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp.1992—
+1K970400Bone Source HydroxyapatiteOrthofix, Inc.1997—
+2K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair…Norian Corp.1998—
+1K022665Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks…Hohenstein Enterprises, Inc.2002—
+2K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger1999—
+1K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical…Ceremed, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
199920
200230
200320
200410
200540
200650
200740
200840
200930
201030
201192
201260
201350
201490
201550
201680
201730
201830
201970
202040
202140
202250
2023110
202470
202510
2026110
FIG. 1 — Lineage of K922489, 1992–2026Source: 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.

2 devices in this family have a Class I recall. 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 FWP device

  1. #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 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? (132)

See all 132

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

NumberDeviceApplicantDecidedDescendants
K970400Bone Source HydroxyapatiteOrthofix, Inc.199750
K022665Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including…Hohenstein Enterprises, Inc.200246
K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc.200543
K083621Medpor Customized Surgical ImplantPorex Surgical, Inc.200929
K123908Omnipore Surgical Implants and AccessoriesMatrix Surgical USA20135
K140437SU-Por Surgical ImplantPoriferous, LLC20142
K091120Medpor Contain ImplantPorex Surgical, Inc.20101
K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc.20160
K960656Gore Burr Hole CoverW. L. Gore & Associates, Inc.19960

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 17, 2014Class IIZ-1090-2015Process controlPotential for implant damage, implant cracking off/breaking intra-operatively.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
  • K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K970400 (Orthofix, Inc., 1997) has gone furthest, with 50 descendants of its own.

How does its category compare?

All FWP devices

FWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWP

1in 2023

2009: 12012: 12014: 12015: 12016: 22019: 22020: 12023: 12026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FWP

Too few FWP 510(k)s in any year since 2007 to give a median.

Recalls per year · FWP

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

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

Adverse event reports per year · FWP

17in 2025

2007: 32008: 32009: 52010: 12011: 222012: 62013: 92014: 52015: 82016: 62017: 132018: 72019: 152020: 62021: 132022: 122023: 62024: 102025: 17
2007high 22 (2011) · low 1 (2010)2025

MAUDE reports naming product code FWP, 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
20070—03
20080—03
20091—05
20100—01
20110—022
20121—06
20130—09
20141—05
20151—08
20162—06
20170—013
20180—07
20192—015
20201—06
20210—013
20220—012
20231—06
20240—010
20250—117
20261—0—

More from Porex Technologies Corp.

2 FDA decisions under this applicant name. See the company

  • K971583Medpor Ocular Screw and AcceossoriesPorex Technologies Corp. · 1997

Recent decisions in FWP

The FWP category page

  • K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG · 2026
  • K232593FITme Customized Silicone ImplantKeosan Trading Co. · 2023
  • K200610Customized Contour ImplantImplantech Associates, Inc. · 2020
  • K191130Customized Contour ImplantImplantech Associates, Inc. · 2019
  • K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG · 2019

https://510kreport.com/device/K922489 · printed Nov 4, 2026

Cite this page

510(k) Report. “K922489: Medpor Surg Implant Material:Prefor Cran/Fac Impla.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K922489

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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