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K Number
K961578

Validate with FDA (Live)

Device Name
SUTURE ANCHOR
Manufacturer
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
Date Cleared
1996-07-10

(77 days)

Product Code
JDR
Regulation Number
888.3030
Type
Traditional
Panel
Orthopedic
Age Range
All
Reference & Predicate Devices
K954443
Predicate For
K973281
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures

Device Description

Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device (Surgical Dynamics™ Suture Anchor), not an AI/ML powered device. The document describes substantial equivalence to a predicate device, rather than providing acceptance criteria and a study demonstrating performance of an AI/ML model.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device studies. The provided text is a regulatory filing focused on establishing similarity to an existing device for market clearance.

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United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Suture Anchor**

JUL 1 0 1996

SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:

As is evident in the submitted information on indications, design, materials, manufacturing, sterilization, packaging and method of use, the Surgical Dynamics™ Suture Anchor** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Suture Anchor (K954443) and other currently market devices by United States Surgical Corporation.

  • Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
  • Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
  • . Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® Suture Anchor (K954443) are comprised of biosafe materials.
  • . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.
  • . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are manufactured in the same facilities, using the same materials and process methods and controls.
  • . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are packaged in similar facilities, with the same materials and with the same process methods and controls.
  • . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are sterilized in the same facilities, with the same materials and with the same process methods and controls.

N/A