Cleared Traditional

K964226 - MEMORY STAPLE (20 SIZES AVAILABLE)

K964226 is an FDA 510(k) clearance for MEMORY STAPLE (20 SIZES AVAILABLE), manufactured by Landos, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K964226 · Landos, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
286d
Days
Class 2
Risk

K964226 is an FDA 510(k) clearance for the MEMORY STAPLE (20 SIZES AVAILABLE). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Landos, Inc. (Potomac, US). The FDA issued a Cleared decision on August 5, 1997 after a review of 286 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Landos, Inc. devices

FDA 510(k) Submission Details - K964226

510(k) Number K964226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date August 05, 1997
Days to Decision 286 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 122d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDR Staple, Fixation, Bone

All 159
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K964226.
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · Orthopaedic Biosystems, Ltd. · Mar 1999
MITEK MICRO ANCHOR
K982420 · Mitek Products · Aug 1998
LACTOSORB POP RIVET
K981798 · Biomet, Inc. · Jul 1998
HOWMEDICA MAINSTAY ANCHOR
K965175 · Howmedica Corp. · Mar 1997
MLI MODULAR STAPLE
K962705 · Medicinelodge, Inc. · Oct 1996
MITEK MICRO ANCHOR
K962793 · Mitek Products · Oct 1996