Cleared Traditional

K981789 - LORENZ PECTUS SUPPORT BAR STABILIZER

K981789 is an FDA 510(k) clearance for LORENZ PECTUS SUPPORT BAR STABILIZER, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K981789 · Walter Lorenz Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
54d
Days
Class 2
Risk

K981789 is an FDA 510(k) clearance for the LORENZ PECTUS SUPPORT BAR STABILIZER. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 13, 1998 after a review of 54 days - a notably fast clearance 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: 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 Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K981789

510(k) Number K981789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1998
Decision Date July 13, 1998
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K981789.
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913 · Pacific Materials and Interfaces · Jul 1998
DISTAL RADIUS FRACTURE FIXATION PLATE
K981715 · Avanta Orthopaedics, Inc. · Jul 1998
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
K981775 · Depuy Ace Medical Co. · Jul 1998
ARTHREX PUDDU OSTEOTOMY SYSTEM
K973812 · Arthrex, Inc. · Jun 1998
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · Howmedica, Inc. · Jun 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · Depuy, Inc. · Apr 1998