Who else makes this device?

Name: Comprehensive SRS HEX Driver
Brand: Comprehensive SRS HEX Driver

Orthopedic › ProstheticProsthesis, Elbow, Constrained, Cemented

Comprehensive SRS HEX Driver

Catalogue number 405234, listed by Biomet Orthopedics, United States, under Prosthesis, Elbow, Constrained, Cemented. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code JDC
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Comprehensive SRS HEX Driver
Listed by	Biomet Orthopedics, United States
FDA product code	JDC
Device type	Prosthesis, Elbow, Constrained, Cemented
Device class	Class 2
Regulation	21 CFR 888.3150
510(k)	K111746
Record published	2016-10-27
Record revised	2025-05-30 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Comprehensive SRS HEX Driver
Catalogue number	Size	Status
405234	3.5MM	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nexel®	Zimmer, Inc.	78
DJO Surgical	Encore Medical, L.P.	74
Tema Elbow	Limacorporate	72
Discovery Elbow System	Biomet Orthopedics	72
Arcos Modular Revision Hip System	Biomet Orthopedics	58
Latitude™ – Elbow	Tornier Inc.	38
Prosthesis, Elbow, Constrained, Cemented	Zimmer, Inc.	37
Latitude™ EV	Tornier Inc.	36
Comprehensive® SRS	Biomet Orthopedics	31
Comprehensive® SRS Instrument	Biomet Orthopedics	30
Solar	Howmedica Osteonics Corp	27
Zimmer® Nexel® Total Elbow	Zimmer, Inc.	23

Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K013042	2001-10-10

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Comprehensive SRS HEX Driver
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Biomet, Inc.	510(k) number	2018-02-28	Class II	Under Investigation by firm	During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly	634	2020-08-11

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.