Who else makes this device?

Name: OsteoBridge™ IKA Knee Arthrodesis Nail
Brand: OsteoBridge™ IKA Knee Arthrodesis Nail

OsteoBridge™ IKA Knee Arthrodesis Nail · Rod, Fixation, Intramedullary and Accessories → Orthopedic

OsteoBridge IKA is a modular intramedullary rod system for knee arthrodesis. Proximal and distal segments join to form the internal fixation construct spanning the knee fusion site.

A hollow, angled attachment shell clamps the segments together with multiple screws. Titanium alloy forms the components, and interlocking screws secure the intramedullary rods to bone.

Segment Options

The range includes nails with or without a collar, in different diameters and lengths. The fixation can use interlocking screws with or without bone cement, providing different anchoring configurations within the modular reconstruction system.

17manufacturers in China registered for this device type

33catalogue numbers in this listing

6510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HSB
Manufacturer	City	Province	Registered as	Device types
Zhejiang Biomet Medical Products Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	74
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Changzhou Biomet Medical Devices Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	54
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Canwell Medical Co., Ltd.	Jinhua	Zhejiang	Contract manufacturer	42
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Stryker (Suzhou) Medical Technology Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Suzhou Ahno Medical Devices Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	17
Turnxon Precision Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	17
Suzhou Kangli Orthopaedics Instrument Co., Ltd.	Zhangjiagang	Jiangsu	Contract manufacturer	11
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Shanghai JPY ION-Tech Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	70

Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories

Record

Regulatory record for OsteoBridge™ IKA Knee Arthrodesis Nail
Listed by	Merete Gmbh, Germany
FDA product code	HSB
Device type	Rod, Fixation, Intramedullary And Accessories
Device class	Class 2
Regulation	21 CFR 888.3020
Establishment	Specification developer, Manufacturer
510(k)	K101939
Record published	2015-10-15
Record revised	2026-03-18 (version 9)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date
Sizes	Length 130 to 300 mm; outer diameter 10 to 20 mm

Catalogue Numbers

Catalogue numbers for OsteoBridge™ IKA Knee Arthrodesis Nail
Catalogue number	Size	Status
with Collar 16 150	Length 150 mm	In distribution
without Collar curved 16 300	Length 300 mm	In distribution
with Collar 12 200	Length 200 mm	In distribution
with Collar 14 200	Length 200 mm	In distribution
without Collar 20 200	Length 200 mm	In distribution
without Collar 18 150	Length 150 mm	In distribution
with Collar 16 200	Length 200 mm	In distribution
with Collar 14 130	Length 130 mm	In distribution
with Collar 18 130	Length 130 mm	In distribution
without Collar curved 14 300	Length 300 mm	In distribution
without Collar 16 130	Length 130 mm	In distribution
with Collar 10 150	Length 150 mm	In distribution
without Collar 14 150	Length 150 mm	In distribution
with Collar 10 130	Length 130 mm	In distribution
without Collar 20 150	Length 150 mm	In distribution
with Collar 12 150	Length 150 mm	In distribution
without Collar curved 16 250	Length 250 mm	In distribution
without Collar curved 18 300	Length 300 mm	In distribution
with Collar 16 130	Length 130 mm	In distribution
without Collar 18 200	Length 200 mm	In distribution
without Collar curved 14 250	Length 250 mm	In distribution
without Collar 14 200	Length 200 mm	In distribution
without Collar curved 18 250	Length 250 mm	In distribution
without Collar curved 20 300	Outer Diameter 20 mm	In distribution
without Collar curved 20 250	Length 250 mm	In distribution
without Collar 16 150	Length 150 mm	In distribution
with Collar 18 150	Length 150 mm	In distribution
with Collar 18 200	Length 200 mm	In distribution
without Collar 18 130	Length 130 mm	In distribution
with Collar 14 150	Length 150 mm	In distribution
with Collar 12 130	Length 130 mm	In distribution
without Collar 14 130	Length 130 mm	In distribution
without Collar 16 200	Length 200 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
T2	Stryker GmbH	1,373
Autobahn	Globus Medical, Inc.	1,258
Gamma	Stryker GmbH	1,120
Summa Orthopaedics Femur Nail System	Jeil Medical Corporation	742
Arix Femur Nail System	Jeil Medical Corporation	742
Orthofix	Orthofix SRL	721
Rod, Fixation, Intramedullary And Accessories	Synthes Gmbh	715
Trigen	Smith & Nephew, Inc.	681
Arthrex®	Arthrex, Inc.	665
Precice® Intramedullary Limb Lengthening System	NuVasive Specialized Orthopedics, Inc.	596
Apex	Orthoxel Designated Activity Company	569
Natural Nail®	Zimmer, Inc.	552

Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181026	2018-10-17
K142451	2015-02-09
K120978	2012-05-02
K113303	2011-12-09
K101939	2010-10-07
K051965	2006-06-16

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 OsteoBridge™ IKA Knee Arthrodesis Nail
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Merete Gmbh	510(k) number	2020-09-18	Class II	Process design	Product may be mislabeled.	306 units	2021-05-13

Recalls

3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-09-18	Class II	Process design	Product may be mislabeled.	215 units	2021-05-13
2020-09-18	Class II	Process design	Product may be mislabeled.	354 units	2021-05-13
2020-09-18	Class II	Process design	Product may be mislabeled.	144 units	2021-05-13

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.

OsteoBridge™ IKA Knee Arthrodesis Nail