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Synthes (USA) Modular Blade Plate System

by Synthes (Usa)

510(k) K080109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

56 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080109 Date20 Mar 2008ClearedStatusActive

Recalls

56 recalls · FDA

  • 56 recalls, same reason

    • Terminated Z-1279-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1312-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1304-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1316-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1288-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-300-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1290-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1317-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1301-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1305-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1298-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1295-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1269-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1286-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1276-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1273-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1292-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1303-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1266-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010 on shared 510(k) K080109
    • Terminated Z-1271-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1263-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1278-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1262-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1315-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1311-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1274-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1275-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1284-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1265-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1272-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1281-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1296-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1293-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1309-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1310-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1299-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1268-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1282-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1264-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1270-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1302-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1308-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1297-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1307-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1306-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1267-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1283-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1318-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1261-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1280-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1285-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1314-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1289-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1277-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1313-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010
    • Terminated Z-1294-2011 FDA Unclassified (pre-2012) initiated 27 Oct 2010

    Potential for out of specification star grind teeth.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KTW
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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