Memograph Osstaple

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System

510(k) Number

K001354 ↗

FDA Product Code

JDR

Models / Variants

Memograph

Osstaple - Orthopedic Uses For Small Bone And Fragment Fixation For The Memograph Staple System

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Hammerlock

  Class II

  FDA 510(k) K091951 Active Cleared 19 Feb 2010

• Bone and Marrow Collection System Kit

  Class I

  FDA 510(k) K971782 Active Cleared 29 Jul 1997

• Osstaple Chill

  Class II

  FDA 510(k) K102107 Active Cleared 3 Sep 2010

• Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System

  Class II

  FDA 510(k) K001219 Active Cleared 21 Jun 2000

• Memograph Staple, Warm System

  Class II

  FDA 510(k) K993714 Active Cleared 25 Feb 2000

• Bme Bone Drill Bits

  Class I

  FDA 510(k) K964073 Active Cleared 14 Nov 1996

See all devices from Biomedical Ent., Inc. →

• What types of orthopedic procedures is the Memograph Osstaple designed to assist with specifically?

  The Memograph Osstaple is specifically designed for securing small bone fragments or stabilizing small bones during orthopedic surgeries. It is intended to provide stable internal fixation to aid in fracture healing or joint stabilization, particularly in cases where traditional wiring or plating might be less practical or more complex.

• Is the Memograph Osstaple reusable or intended for single-use, and how is it supplied?

  The Memograph Osstaple is supplied as a sterile, single-use device, intended exclusively for surgical settings. This ensures patient safety and maintains sterility, as reuse could compromise integrity and introduce infection risks.

• What storage conditions are required to maintain the device’s sterility and functionality?

  The Memograph Osstaple must be stored under conditions that preserve its sterility and functionality. While specific storage instructions aren’t detailed in the data, typical orthopedic fixation devices require protection from moisture, extreme temperatures, and physical damage—often in sealed packaging until use.

• Can this device be used in MRI scans, or are there any special considerations for imaging?

  The Memograph Osstaple is not MRI-safe, meaning it should not be used in patients who require MRI imaging. Clinicians should confirm alternative imaging modalities or remove the device if MRI is necessary, as metal-based fixation devices can interfere with MRI scans.

• How is the Memograph Osstaple regulated, and what does its FDA clearance status indicate?

  The Memograph Osstaple received FDA 510(k) clearance (K001354) under the product code JDR, classified as substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as determined by the Orthopedic (OR) Advisory Committee in 2001, ensuring it complies with regulatory requirements for orthopedic fixation staples.