510(k) Report

510(k) · Cleared

Cleared

KLS Martin Quick Disc

K062857510(k) TraditionalCleared Nov 22, 200658-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

KLS Martin L.P. · GXN Plate, Cranioplasty, Preformed, Non-Alterable

Cleared on Nov 22, 2006 as substantially equivalent to K040864 (Aesculap, 2004) and 4 other predicates after a 58-day review. Its family tree reaches back 3 generations to 1998. 62 later devices descend from it.

Decided
Nov 22, 2006
Review
58 days
Class
Class II
Product code
GXN
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K971252 (1998). 9 ancestors in all, the oldest K923705 (1994). 62 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor2001: 1 other ancestor1994: 1 other ancestor2007: 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. · 1999K022277 · Osteomed Cranial Flap Fixation System · Osteomed Corp. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 7 descendants5 generations forward: 8 descendants6 generations forward: 14 descendants7 generations forward: 17 descendants8 generations forward: 2 descendants K022277 · Osteomed Cranial Flap Fixation System · Osteomed Corp. · 2003K991029 · Rapidflap Cranial Clamp · Walter Lorenz Surgical, Inc. · 1999K971252 · Sevrain Cranial Clamp · Ikonos Corp. · 19980+5
  1. Root · 3 generations backK971252 Sevrain Cranial ClampIkonos Corp. · 1998
  2. 2 generations backK991029 Rapidflap Cranial ClampWalter Lorenz Surgical, Inc. · 1999
  3. 1 generation backK022277 Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  4. This deviceK062857 KLS Martin Quick DiscKLS Martin L.P. · 2006
  5. Descendant · cites it directly · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
  6. Descendant · 2 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  7. Descendant · 3 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 · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
  9. Descendant · 5 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12012: 12013: 12014: 32015: 22016: 22021: 32022: 32023: 82024: 122025: 142026: 11
2007high 14 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 62 · See all
  • K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · cites it directly61descendants
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 2 generations on45descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 3 generations on39descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
  • K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 5 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K971252Sevrain Cranial ClampIkonos Corp.1998—
−2K991029Rapidflap Cranial ClampWalter Lorenz Surgical, Inc.1999—
−1K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp.2003—
0 (this device)K062857KLS Martin Quick DiscKLS Martin L.P.2006—
+1K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.2007—
+2K151983KLS Martin LSS Plating SystemKLS Martin L.P.2016—
+3K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+4K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—
+5K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810
199910
200110
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
201210
201310
201430
201520
201620
202130
202230
202380
2024120
2025140
2026110
FIG. 1 — Lineage of K062857, 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? (5)

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
*K040864Craniofix and CRANIOFIX2 Titanium Clamp System
Summary page 1
…reformed Nonalterable Craniopiasty Plate (CFR 882.5330) Regulatory Class: II Predicate Devices: CranioFix Titanium Clamp System (K040864) Spin Down RapidFlap (K031034) OsteoMed Cranial Flap Fixation Sys…
Aesculap2004—
*K031034Spin Down Rapidflap
Summary page 1
…(CFR 882.5330) Regulatory Class: II Predicate Devices: CranioFix Titanium Clamp System (K040864) Spin Down RapidFlap (K031034) OsteoMed Cranial Flap Fixation System (K022277)…
Walter Lorenz Surgical, Inc.20036
*K022277Osteomed Cranial Flap Fixation System
Summary page 1
…m (K040864) Spin Down RapidFlap (K031034) OsteoMed Cranial Flap Fixation System (K022277) Synthes Cranial Flap Twist Clamp (K991 860) Aesculap CranioFix Titanium Clamp…
Osteomed Corp.2003—
*K991860Synthes Cranial Flap Twist Clamp
Summary page 1
…OsteoMed Cranial Flap Fixation System (K022277) Synthes Cranial Flap Twist Clamp (K991 860) Aesculap CranioFix Titanium Clamp System (K972332) Intended Use: Th…
Synthes (Usa)1999—
*K972332Aesculap Craniofix Titanium Clamp System
Summary page 1
…K022277) Synthes Cranial Flap Twist Clamp (K991 860) Aesculap CranioFix Titanium Clamp System (K972332) Intended Use: The KLS Martin Quick Disc is intended for use in the reattachment of cranial b…
Aesculap, Inc.1998—

Also cleared against K040864: 3 other devices →

What descends from it? (62)

See all 62

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

NumberDeviceApplicantDecidedDescendants
K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P.200761

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 8 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K070169 (KLS Martin L.P., 2007) has gone furthest, with 61 descendants of its own.
  • 3 other devices also cite its predicate K040864.

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?

The KLS Martin Quick Disc is intended for use in the reattachment of cranial bone flaps after a craniotomy, covering burr holes, and fixation of cranial fractures.

Indications for use as stated in the FDA summary.

Also cleared against K040864

3 other devices cite the same predicate.

  • K130447Speedy Flap SystemJeil Medical Corporation · 2014
  • K122353Crainfix 2 Titanium Clamp SystemAesculap, Inc. · 2012
  • K063017Aesculap Sternumfix Sternal Closure SystemAesculap, Inc. · 2006

More from KLS Martin L.P.

20 FDA decisions under this applicant name. See the company

  • K254162KLS Martin Ixos SystemKLS Martin L.P. · 2026
  • K250620KLS Martin Ixos SystemKLS Martin L.P. · 2025
  • K221938KLS Martin Pure Pectus SystemKLS Martin L.P. · 2023
  • K220050KLS Martin IPS DistractionKLS Martin L.P. · 2022
  • K173320KLS Martin L1 MMF SystemKLS Martin L.P. · 2018

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/K062857 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062857: KLS Martin Quick Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062857

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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