510(k) Report

510(k) · Cleared

Cleared

Osteomed Temporary Condylar Attachment System

K031701510(k) TraditionalCleared Jul 8, 2004402-day reviewClass II21 CFR 872.4770

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

Osteomed LP · NEI Prosthesis, Condyle, Mandibular, Temporary

Cleared on Jul 8, 2004 as substantially equivalent to K990667 (KLS-Martin L.P., 2001) and 2 other predicates after a 402-day review. Its family tree reaches back 1 generation to 2000.

Decided
Jul 8, 2004
Review
402 days
Class
Class II
Product code
NEI
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K000594 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestorsK000594 · Locking Screw Mandibular Reconstruction Plate · Stryker Leibinger · 20002000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K000594 · Locking Screw Mandibular Reconstruction Plate · Stryker Leibinger · 20000
  1. Root · 1 generation backK000594 Locking Screw Mandibular Reconstruction PlateStryker Leibinger · 2000
  2. This deviceK031701 Osteomed Temporary Condylar Attachment SystemOsteomed LP · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000594Locking Screw Mandibular Reconstruction PlateStryker Leibinger2000—
0 (this device)K031701Osteomed Temporary Condylar Attachment SystemOsteomed LP2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
FIG. 1 — Lineage of K031701, 2000–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 NEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K990667KLS-Martin Temporary Condylar Implant
Summary page 1
…vice is based on similarities in intended use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plat…
KLS-Martin L.P.2001—
*K002790Add-on Condyle
Summary page 1
…d use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594). Due to the…
Walter Lorenz Surgical, Inc.2001—
*K000594Locking Screw Mandibular Reconstruction Plate
Summary page 1
…lar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594). Due to the similarity of materials and design to predicate devices, OsteoMed believes that the…
Stryker Leibinger2000—

Also cleared against K990667: 2 other devices →

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?

  • None of the 3 ancestors has a recall.
  • 2 other devices also cite its predicate K990667.

How does its category compare?

All NEI devices

NEI Prosthesis, Condyle, Mandibular, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NEI

1in 2014

2007: 12008: 12014: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEI

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

Recalls per year · NEI

No recall names NEI since 2007.

Adverse event reports per year · NEI

2in 2024

2013: 12014: 32015: 12018: 32019: 62021: 82024: 2
2007high 8 (2021) · low 0 (2007)2025

MAUDE reports naming product code NEI, 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—00
20090—00
20100—00
20110—00
20120—00
20130—01
20141—03
20150—01
20160—00
20170—00
20180—03
20190—06
20200—00
20210—08
20220—00
20230—00
20240—02
20250—00
20260—0—

What is it indicated for?

Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.

Indications for use as stated in the FDA summary.

Also cleared against K990667

2 other devices cite the same predicate.

  • K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P. · 2024
  • K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003

More from Osteomed LP

29 FDA decisions under this applicant name. See the company

  • K143338Argulated Locking PlatesOsteomed LP · 2015
  • K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014
  • K131445Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
  • K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
  • K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 2012

Recent decisions in NEI

The NEI category page

  • K133285Stryker Temporary Condylar ProsthesisStryker · 2014
  • K081747Modification to Synthes (Usa) Condylar Head Add-on SystemSynthes (Usa) · 2008
  • K063181Synthes (Usa) Condylar Head Add-on SystemSynthes (Usa) · 2007
  • K002790Add-on CondyleWalter Lorenz Surgical, Inc. · 2001
  • K990667KLS-Martin Temporary Condylar ImplantKLS-Martin L.P. · 2001

https://510kreport.com/device/K031701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031701: Osteomed Temporary Condylar Attachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031701

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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