AccessGUDID - DEVICE: InSitu Hip System (00816127022524)

GUDID

Device Identifier (DI) Information

Brand Name: InSitu Hip System
Version or Model: 10-21-4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-21-4000
Company Name: NEXTSTEP ARTHROPEDIX, LLC

Primary DI Number: 00816127022524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 060211165 *Terms of Use

Device Description: Femoral Head, 40mm, -4mm, Biolox

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38156	Ceramic femoral head prosthesis	An implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
OQG	Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQI	Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161184	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 40 Millimeter

Device Record Status

Public Device Record Key: f6ca4dab-93f9-4c4a-ac7a-01c2a4d8914d
Public Version Date: September 09, 2020
Public Version Number: 4
DI Record Publish Date: February 15, 2018