# K080109: Synthes (Usa) Modular Blade Plate System - Pathway: 510(k) (Traditional) - Applicant: Synthes (Usa) - Decided: Mar 20, 2008 after 65 days - Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component) - Device class: 2 - Regulation: 21 CFR 888.3030 - Recalls of this device: 56 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K914546 (1991). 1 ancestor in all. 1 later device descends from it; 1 cites it directly. 0 of 3 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K914546: Angled Blade Plate, Synthes (Usa) (1991) Summary page 1. - (no number) Synthes Angled Blade Plates (Pre-amendment): named in the summary without a submission number ## Most influential descendants - K170704: The Locking Pediatric Osteotomy Plate (LolliPOP) System (2017), 0 descendants of its own ## Recalls of this device - Oct 27, 2010 · Not classified · Z-1280-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1314-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1308-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1265-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1279-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1302-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1297-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1296-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1269-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1315-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1272-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1281-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1274-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1307-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1270-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1304-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1306-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1267-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1303-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1275-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1316-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1285-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1318-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1268-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1271-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1317-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1305-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1262-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1288-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1292-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1264-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1299-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1289-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1298-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1311-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1293-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1301-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1266-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1286-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1309-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1277-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1284-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1283-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1278-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1294-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-300-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1263-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1310-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1290-2011: Potential for out of specification star grind teeth. - Oct 27, 2010 · Not classified · Z-1313-2011: Potential for out of specification star grind teeth. ## Indications for use The Synthes (USA) Modular Blade Plate System is indicated for fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults. Source page: https://510kreport.com/device/K080109 Methodology: https://510kreport.com/methodology