Description
This guidance document provides the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions.
Scope & Applicability
Product Classes
8Non-spinal, non-resorbable bone plates, screws and washers are class II medical devices
devices subject to MR compatibility evaluation
bone plates, screws, and washers categorized as prescription devices
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
General manual surgical instruments exempt from 510(k)
characteristics not specifically addressed by this guidance
characteristics not specifically addressed by this guidance
legally marketed device used for substantial equivalence comparison
Stakeholders
1newborn, infant, child, and adolescent groups
Regulatory Context
Attributes
7Determined by the sponsor for the investigational product.; investigational product(s) are stable over the period of use and only used within the current shelf life
Observed method of failure for the screw upon insertion or release.
The specific device configuration selected for testing; The specific device configuration selected for testing to represent the most challenging conditions.
Device risk determination
Selection of screw versions most likely to fail for testing
Regulatory standard for 510(k) clearance; demonstration required for 510(k) submission; regulatory standard for 510(k) clearance; Comparison of subject device parameters to predicate 510(k) submission numbers.
conformity with an FDA-recognized standard can help demonstrate that an NGS-based test developer has performed the activities necessary to identify the indications for use; number and types of samples used in the study should be statistically justified for the test’s indications for use; If a modification expands the indications for use beyond aiding in the diagnosis of symptomatic individuals; Acceptable performance levels depend on these
Identified Hazards
Hazards
7Risk from contact between dissimilar metals
risk from changing sterilization methods
risk associated with material changes
potential hazard in MR environment
biocompatibility endpoint for patient-contacting devices
chemicals leaching from device causing febrile reaction
risk of febrile reaction addressed by pyrogenicity testing
Related CFR Sections (9)
- 21CFR807.81§ 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to § 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for inRead full regulation →
- 21CFR812.28§ 812.28 Acceptance of data from clinical investigations conducted outside the United States.
(a) Acceptance of data from clinical investigations conducted outside the United States to support an IDE or a device marketing application or submission (an application under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act, a premarket notification submission under section 510(k) Read full regulation →
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read 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 →
- 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 →
- 21CFR878.4800§ 878.4800 Manual surgical instrument for general use.
(a) Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brusRead full regulation →
- 21CFR888.4540§ 888.4540 Orthopedic manual surgical instrument.
(a) Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, coRead full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
See Also (8)
- Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology (Status: Final)
- Guidance for the Content of Premarket Notifications for Ureteral Stents (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles (Status: Final)
- Hysteroscopic and Laparoscopic Insufflators: Submission Guidance for a 510(k) (Status: Final)
- Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests (Status: Final)