What is FDA product code OBT?

Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius). The device may be removed when growth has equalized or the growth plate has fused.

Orthopedic › ProstheticPlate, Bone, Growth Control, Pediatric, Epiphysiodesis

Procedure Kit, Curved 2 Hole X 16mm EpiFIX Plate, Instruments and Screws, Ti

Name: Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti
Brand: Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti

2 catalogue numbers from PK-EFC0216T, listed by Wishbone Medical Inc., United States, under Plate, Bone, Growth Control, Pediatric, Epiphysiodesis. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

2catalogue numbers in this listing

1510(k) clearance

1recall

Who Else Makes It

Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OBT
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53

Record

Regulatory record for Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti
Listed by	Wishbone Medical Inc., United States
FDA product code	OBT
Device type	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K182704
Record published	2019-09-10
Record revised	2024-02-19 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Distribution end date	2021-12-31

Catalogue Numbers

Catalogue numbers for Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti
Catalogue number	Size	Status
PK-EFC0216T		Withdrawn
PK-EFC0216T-US		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
WishFIX	Wishbone Medical Inc.	248
EpiFIX	Wishbone Medical Inc.	240
WishFIX	RED Star Contract Manufacturing Inc.	124
Guided Growth Plate System	Orthofix SRL	42
Giro Growth Modulation System	Orthopediatrics Canada ULC	35
Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti	Wishbone Medical Inc.	2
Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, Ti	Wishbone Medical Inc.	2
Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, Ti	Wishbone Medical Inc.	2

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K182704	2019-06-25

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 Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Wishbone Medical Inc.	510(k) number	2024-04-05	Class II	Nonconforming Material/Component	The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.	60 units

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.