510(k) Report

510(k) · Cleared

Cleared

Osteomed Cranial Flap Fixation System

K022277510(k) TraditionalCleared Apr 1, 2003260-day reviewClass II21 CFR 882.5330

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

Osteomed Corp. · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Apr 1, 2003 as substantially equivalent to K002334 (Macropore Biosurgery, Inc., 2001) and 2 other predicates after a 260-day review. Its family tree reaches back 2 generations to 1998. 63 later devices descend from it.

Decided
Apr 1, 2003
Review
260 days
Class
Class II
Product code
GXN
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K971252 (1998). 4 ancestors in all, the oldest K972332 (1998). 63 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1998: 1 other ancestor2006: 1 descendant cleared2007: 1 descendant cleared2016: 2 descendants cleared2012: 1 descendant cleared2014: 3 descendants cleared2011: 1 descendant cleared2024: 12 descendants cleared2013: 1 descendant cleared2021: 3 descendants cleared2023: 8 descendants cleared2025: 14 descendants cleared2022: 3 descendants cleared2026: 11 descendants cleared2015: 2 descendants clearedK971252 · Sevrain Cranial Clamp · Ikonos Corp. · 1998K991029 · Rapidflap Cranial Clamp · Walter Lorenz Surgical, Inc. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 6 descendants4 generations forward: 7 descendants5 generations forward: 7 descendants6 generations forward: 8 descendants7 generations forward: 14 descendants8 generations forward: 17 descendants9 generations forward: 2 descendants K991029 · Rapidflap Cranial Clamp · Walter Lorenz Surgical, Inc. · 1999K971252 · Sevrain Cranial Clamp · Ikonos Corp. · 19980+5
  1. Root · 2 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
  2. 1 generation backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
  3. This deviceK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  4. Descendant · cites it directly · 62 of its ownK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
  5. Descendant · 2 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  6. Descendant · 3 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  7. Descendant · 4 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  8. Descendant · 5 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022

Showing 5 of 63 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12011: 12012: 12013: 12014: 32015: 22016: 22021: 32022: 32023: 82024: 122025: 142026: 11
2006high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 63 · See all
  • K062857KLS Martin Quick DiscKLS Martin L.P. · 2006 · cites it directly62descendants
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 2 generations on61descendants
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 3 generations on45descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 4 generations on39descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 5 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K971252Sevrain Cranial ClampIkonos Corp.1998—
−1K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc.1999—
0 (this device)K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.2003—
+1K062857KLS Martin Quick DiscKLS Martin L.P.2006—
+2K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+3K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—
+4K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+5K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
201110
201210
201310
201430
201520
201620
202130
202230
202380
2024120
2025140
2026110
FIG. 1 — Lineage of K022277, 1998–2026Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXN? 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 GXN device

  1. #1 K260709 ClearFit Ti Ring 14mm (171750);ClearFit Ti…score 13.7 · 8 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? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K002334Macroporens Craniloc
Summary page 1
…Equivalence for this device is based on similarities in intended use, material, design and operational principle to the MacroPore CraniLoc (K002334), Aesculap Craniofix Titanium Clamp System (K972332) and the Lorenz Rapidflap Cranial Clamp (K99102…
Macropore Biosurgery, Inc.2001—
*K972332Aesculap Craniofix Titanium Clamp System
Summary page 1
…in intended use, material, design and operational principle to the MacroPore CraniLoc (K002334), Aesculap Craniofix Titanium Clamp System (K972332) and the Lorenz Rapidflap Cranial Clamp (K991029). Due to the similarity of materials and design t…
Aesculap, Inc.1998—
*K991029Rapidflap Cranial Clamp
Summary page 1
…l principle to the MacroPore CraniLoc (K002334), Aesculap Craniofix Titanium Clamp System (K972332) and the Lorenz Rapidflap Cranial Clamp (K991029). Due to the similarity of materials and design to both pre-enactment and post- enactment devices,…
Walter Lorenz Surgical, Inc.1999—

Also cleared against K002334: 1 other device →

What descends from it? (63)

See all 63

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062857KLS Martin Quick DiscKLS Martin L.P.200662

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K062857 (KLS Martin L.P., 2006) has gone furthest, with 62 descendants of its own.
  • 1 other device also cites its predicate K002334.

How does its category compare?

All GXN devices

GXN Plate, Cranioplasty, Preformed, Non-Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXN

2in 2025

2007: 22008: 12011: 22012: 32013: 12014: 22015: 22016: 12017: 22018: 32020: 52021: 32022: 22023: 12024: 12025: 22026 (partial year): 4
2007high 5 (2020) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXN

69in 2021

2012: 102 days median2018: 199 days median2020: 33 days median2021: 69 days median2026 (partial year): 193 days median
2007high 199 (2018) · low 33 (2020)2026

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

Recalls per year · GXN

6in 2018

2018: 6
2007high 6 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GXN

24in 2025

2007: 32008: 172009: 172010: 232011: 202012: 292013: 572014: 602015: 472016: 352017: 742018: 562019: 542020: 632021: 632022: 572023: 322024: 352025: 24
2007high 74 (2017) · low 3 (2007)2025

MAUDE reports naming product code GXN, 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
20072—03
20081—017
20090—017
20100—023
20112—020
20123102029
20131—057
20142—060
20152—047
20161—035
20172—074
20183199656
20190—054
2020533063
2021369063
20222—057
20231—032
20241—035
20252—024
202641930—

What is it indicated for?

Intended for the re-attachment of the bone flap after a craniotomy.

The OsteoMed Cranial Flap Fixation System is intended for single patient use only.

Indications for use as stated in the FDA summary.

Also cleared against K002334

1 other device cites the same predicate.

  • K040080Aesculap Absorbable CraniofixAesculap, Inc. · 2004

More from Osteomed Corp.

27 FDA decisions under this applicant name. See the company

  • K151021OsteoMed Cannulated Screw SystemOsteomed Corp. · 2015
  • K022887Interphalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K022886Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
  • K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002

Recent decisions in GXN

The GXN category page

  • K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm…Longeviti Neuro Solutions · 2026
  • K2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA) · 2026
  • K252251Easymade-TICG Bio Co., Ltd. · 2026
  • K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd. · 2026
  • K243715Synthes Patient Specific ImplantsSynthes GmbH · 2025

https://510kreport.com/device/K022277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022277: Osteomed Cranial Flap Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022277

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026