Who else makes this device?

Name: bioBLOCK® Subtalar Implant System
Brand: bioBLOCK® Subtalar Implant System

Orthopedic › ProstheticProsthesis, Subtalar, Plug, Polymer

bioBLOCK® Subtalar Implant System

The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding…

Registry build 21.09.26

The bioBLOCK Subtalar Implant consists of a soft-threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint, trial implant and the corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement. The implant is indicated as an internal support in the treatment of flat foot, providing structural support.

1manufacturer

3catalogue numbers in this listing

Who Else Makes It

Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MJW
Manufacturer	City	Province	Registered as	Device types
Kingj Medical Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	7

Record

Regulatory record for bioBLOCK® Subtalar Implant System
Listed by	Ascension Orthopedics, Inc., United States
FDA product code	MJW
Device type	Prosthesis, Subtalar, Plug, Polymer
Device class	Class 2
Regulation	21 CFR 888.3040
Establishment	Manufacturer
510(k)	K051611
Record published	2017-10-09
Record revised	2025-02-06 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Special storage condition: Avoid contact with any objects that may damage the surface finish. Must be stored cool. Do not freeze.; Storage environment temperature 0 to 43 °C; Storage environment temperature 0 to 110 °F
Distribution end date	2026-12-31

Catalogue Numbers

Catalogue numbers for bioBLOCK® Subtalar Implant System
Catalogue number	Size	Status
040008	8 mm dia x 15 mm L	In distribution
040010	10 mm dia x 15 mm L	In distribution
40012	12 mm dia x 15 mm L	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LSI Arthroereisis Peg	Fusion Orthopedics, LLC	42

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of bioBLOCK® Subtalar Implant System
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Integra Medical	510(k) number	2019-03-01	Class II	Process control	Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F	232 total	2020-06-22
Integra Medical	510(k) number	2019-03-01	Class II	Process control	Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F	232 total	2020-06-22
Integra Medical	510(k) number	2019-03-01	Class II	Process control	Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F	232 total	2020-06-22

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.