510(k) Report

510(k) · Cleared

Cleared

Osteonics Cement Restrictor

K900462510(k) TraditionalCleared Mar 6, 199034-day reviewClass II21 CFR 878.3300

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

Osteonics Corp. · JDK Prosthesis, Hip, Cement Restrictor

Cleared on Mar 6, 1990 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 6, 1990
Review
34 days
Class
Class II
Product code
JDK
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK900462 Osteonics Cement RestrictorOsteonics Corp. · 1990
  2. Descendant · cites it directly · 1 of its ownK022729 Vented Cement RestrictorAmedica Corp. · 2002
  3. Descendant · 2 generations on · 0 of its ownK050699 Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005

Most influential descendants

Showing 2 of 2 · See all
  • K022729Vented Cement RestrictorAmedica Corp. · 2002 · cites it directly1descendant
  • K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K900462Osteonics Cement RestrictorOsteonics Corp.1990—
+1K022729Vented Cement RestrictorAmedica Corp.2002—
+2K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200510
FIG. 1 — Lineage of K900462, 1990–2005Source: 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.

Planning a device in JDK? 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 JDK device

  1. #1 K210062 Mectaplug PE IIscore 5.0 · 14 generations · no Class I recall
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K022729Vented Cement RestrictorAmedica Corp.20021

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?

  • Of its descendants, K022729 (Amedica Corp., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JDK devices

JDK Prosthesis, Hip, Cement Restrictor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDK

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDK

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

Recalls per year · JDK

5in 2011

2007: 62011: 5
2007high 6 (2007) · low 0 (2008)2026

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

Adverse event reports per year · JDK

6in 2025

2007: 32008: 52009: 12010: 22011: 32012: 12013: 32014: 22015: 72016: 22018: 12019: 132020: 42021: 32022: 42023: 72024: 52025: 6
2007high 13 (2019) · low 0 (2017)2025

MAUDE reports naming product code JDK, 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—63
20080—05
20090—01
20100—02
20110—53
20120—01
20130—03
20140—02
20150—07
20160—02
20170—00
20180—01
20190—013
20200—04
20211—03
20220—04
20230—07
20240—05
20250—06
20260—0—

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in JDK

The JDK category page

  • K210062Mectaplug PE IIMedacta International S.A. · 2021
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K061698Modification to Life Spine Cement RestrictorLife Spine · 2006
  • K060247Life Spine Cement RestrictorLife Spine · 2006
  • K060132Spinal Usa Cement Restrictor SystemSpinal USA · 2006

https://510kreport.com/device/K900462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K900462: Osteonics Cement Restrictor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K900462

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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