Description
This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of theSafety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of orthopedic non-spinal metallic bone screws and washers.
Scope & Applicability
Product Classes
3The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Excluded from the scope of this guidance
Subject of the mechanical testing requirements
Stakeholders
1Legally marketed device used for comparison
Regulatory Context
Attributes
2Performance criteria for sterilization validation
Selection of screw versions most likely to fail for testing
Related CFR Sections (2)
- 21CFR888.3040§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a) Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straiRead full regulation →
- 21CFR888.3030§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a) Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that arRead full regulation →
See Also (4)
- Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 (Status: Final)
- Bone Anchors - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)