Cleared Traditional

K955632 - ORTHOPLUG SOFT BONE DESIGN

K955632 is an FDA 510(k) clearance for ORTHOPLUG SOFT BONE DESIGN, manufactured by Sunmed, Inc.. The device is a Class 2 Orthopedic device with product code LZN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K955632 · Sunmed, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
78d
Days
Class 2
Risk

K955632 is an FDA 510(k) clearance for the ORTHOPLUG SOFT BONE DESIGN. Classified as Cement Obturator (product code LZN), Class II - Special Controls.

Submitted by Sunmed, Inc. (Redding, US). The FDA issued a Cleared decision on February 27, 1996 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sunmed, Inc. devices

FDA 510(k) Submission Details - K955632

510(k) Number K955632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date February 27, 1996
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZN Device Classification - Class 2, Special Controls

Product Code LZN Cement Obturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 - LZN Cement Obturator

All 25
Devices cleared under the same product code (LZN) and FDA review panel - the closest regulatory comparables to K955632.
LINK CEMENT PLUG
K972411 · Turnkey Intergration USA, Inc. · Aug 1997
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · Osteonics Corp. · May 1997
ORTHOPLUG HARD BONE DESIGN
K955631 · Sunmed, Inc. · Feb 1996
PRIME FEMORAL CEMENT PLUG
K955751 · Orthopaedic Innovations, Inc. · Jan 1996
CEMENTRALIZER DISTAL STEM CENTRALIZER
K951930 · Depuy, Inc. · Jul 1995
EXETER INTRAMEDULLARY BONE PLUG
K933077 · Howmedica Corp. · May 1995