Cleared Traditional

ACE INTRAMEDULLARY ROD FOR SMALL BONES (K850142) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K850142 · Buckman Co., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
24d
Days
Class 2
Risk

K850142 is an FDA 510(k) clearance for the ACE INTRAMEDULLARY ROD FOR SMALL BONES. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K850142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 07, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 257
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K850142.
HI MARC INTERLOCKING NAIL
K871872 · Depuy, Inc. · Jun 1987
GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
K860756 · Howmedica Corp. · Mar 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · Zimmer, Inc. · Feb 1986
GROSSE AND KEMPF LOCKING NAIL SYS.
K813371 · Howmedica Corp. · Mar 1982
MOURADIAN MODIFIED ZICKEL HUMERAL ROD
K810535 · Howmedica Corp. · Mar 1981
FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM
K803196 · Howmedica Corp. · Feb 1981