OSTEO-PIN MEMBRANE FIXATION PIN

• K Number: K990537
• Device Name: OSTEO-PIN MEMBRANE FIXATION PIN
• Manufacturer: LUITPOLD PHARMACEUTICALS, INC.
• Date Cleared: 1999-11-19 ( 273 days)
• Product Code: LYC
• Regulation Number: 872.3930
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

OSTEO-PIN is used to attach absorbable and non-absorbable membranes used for guided tissue regeneration and guided bone regeneration to underlying bone.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device (OSTEO-PIN Membrane Fixation Pin). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations.

The document does not contain any information about acceptance criteria for a study, reported device performance, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone algorithm performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.