510(k) Report

510(k) · Cleared

Cleared

Neuropro Low Profile Cranial Plating System

K122049510(k) TraditionalCleared Apr 5, 2013267-day reviewClass II21 CFR 882.5320

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

Kinamed, Inc. · GWO Plate, Cranioplasty, Preformed, Alterable

Cleared on Apr 5, 2013 as substantially equivalent to K964362 (Kinamed, Inc., 1997) and 4 other predicates after a 267-day review. Its family tree reaches back 4 generations to 1976.

Decided
Apr 5, 2013
Review
267 days
Class
Class II
Product code
GWO
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K761228 (1976). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1991: 2 other ancestors1994: 2 other ancestors1996: 2 other ancestors1988: 1 other ancestor1986: 2 other ancestorsK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 19981980199020002010
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 6 other ancestors K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 19760
  1. Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 3 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 2 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 1 generation backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. This deviceK122049 Neuropro Low Profile Cranial Plating SystemKinamed, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−3K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−2K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−1K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
0 (this device)K122049Neuropro Low Profile Cranial Plating SystemKinamed, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199120
199420
199510
199620
199720
199810
FIG. 1 — Lineage of K122049, 1976–2013Source: 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 GWO? 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 GWO device

  1. #1 K261058 CraniUS Platescore 16.8 · 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
*K964362Kinamed Profix System
Summary page 1
…Cover HBW, Cranioplasty plate fastener Predicate Devices: K964362 NeuroPro® Cranial Plating .System K982927 NeuroPro® Quick Tap® Bone Screws…
Kinamed, Inc.1997—
*K982927Quick Tap Self Drilling Screw
Summary page 1
…sty plate fastener Predicate Devices: K964362 NeuroPro® Cranial Plating .System K982927 NeuroPro® Quick Tap® Bone Screws K911936 OsteoMed® Fast-Fla pT m Neuro Fixation System…
Kinamed, Inc.1998—
*K911936Osteomed SBF System (SBF)
Summary page 1
…Predicate Devices: K964362 NeuroPro® Cranial Plating .System K982927 NeuroPro® Quick Tap® Bone Screws K911936 OsteoMed® Fast-Fla pT m Neuro Fixation System K953385 Biomet®D ThinFlapTm Lorenz®D Plating System Ne…
Osteomed Corp.1991—
*K953385Lorenz 1.0MM, 1.5MM, 2.0MM System
Summary page 1
…K982927 NeuroPro® Quick Tap® Bone Screws K911936 OsteoMed® Fast-Fla pT m Neuro Fixation System K953385 Biomet®D ThinFlapTm Lorenz®D Plating System Neuro K974785 OsteoMed® Auto-Drive Bone Screw NeuroPro®…
Walter Lorenz Surgical, Inc.19958
*K974785Auto-Drive Bone Screw
Summary page 1
…K911936 OsteoMed® Fast-Fla pT m Neuro Fixation System K953385 Biomet®D ThinFlapTm Lorenz®D Plating System Neuro K974785 OsteoMed® Auto-Drive Bone Screw NeuroPro® Low Profile Cranial Plating System 510(k) February 15, 2013 Secti…
Osteomed Corp.1998—

What descends from it?

No later submission names this one as a predicate yet.

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 37 years and passes through 4 companies; a new generation was cleared every 15.0 years on median.
  • 2 of the 17 ancestors have a recall of any class.

How does its category compare?

All GWO devices

GWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GWO

2in 2025

2007: 12008: 12010: 12011: 22012: 52013: 42014: 32015: 32016: 32017: 22018: 12019: 42021: 12022: 22024: 12025: 22026 (partial year): 2
2007high 5 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWO

196in 2019

2012: 133 days median2013: 249 days median2014: 109 days median2015: 210 days median2016: 125 days median2019: 196 days median
2007high 249 (2013) · low 109 (2014)2026

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

Recalls per year · GWO

2in 2015

2007: 12015: 2
2007high 2 (2015) · low 0 (2008)2026

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

Adverse event reports per year · GWO

237in 2025

2008: 32009: 22010: 72011: 12012: 52013: 72014: 112015: 182016: 182017: 472018: 412019: 142020: 252021: 412022: 532023: 722024: 1492025: 237
2007high 237 (2025) · low 0 (2007)2025

MAUDE reports naming product code GWO, 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—10
20081—03
20090—02
20101—07
20112—01
2012513305
2013424907
20143109011
20153210218
20163125018
20172—047
20181—041
20194196014
20200—025
20211—041
20222—053
20230—072
20241—0149
20252—0237
20262—0—

What is it indicated for?

The NeuroPro® Low Profile Cranial Plating System Family is intended for:

1. Internal fixation of fractures and osteotomies of the cranial skeleton.

2. Internal fixation of cranial bone flap osteotomies.

3. Reconstruction of bony defects and deficits in the cranial skeleton.

The NeuroPro® Low Profile Cranial Plating System is not indicated for use in the spine or high load bearing applications.

Indications for use as stated in the FDA summary.

More from Kinamed, Inc.

33 FDA decisions under this applicant name. See the company

  • K072250Supercable Grip and Plate SystemKinamed, Inc. · 20071 recall
  • K050897Navipro Shoulder Software ModuleKinamed, Inc. · 2005
  • K033668Navipro Knee Software ModuleKinamed, Inc. · 2004
  • K032950Gem Inset Patellar ComponentKinamed, Inc. · 2003
  • K030256Iso-Elastic Cerclage SystemKinamed, Inc. · 2003

Recent decisions in GWO

The GWO category page

  • K262874CraniUS PlateCraniUS, LLC · 2026
  • K261058CraniUS PlateCraniUS, LLC · 2026
  • K250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc. · 2025
  • K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc. · 2025
  • K231834VSP PEEK Cranial Implant3D Systems, Inc. · 2024

https://510kreport.com/device/K122049 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122049: Neuropro Low Profile Cranial Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122049

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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