Cleared Traditional

K850770 - INTERMEDICS BONE SCREW

K850770 is an FDA 510(k) clearance for INTERMEDICS BONE SCREW, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K850770 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
53d
Days
Class 2
Risk

K850770 is an FDA 510(k) clearance for the INTERMEDICS BONE SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on April 19, 1985 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K850770

510(k) Number K850770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1985
Decision Date April 19, 1985
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 640
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K850770.
CANCELLOUS BONE SCREW
K864626 · Dow Corning Wright · Dec 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · Buckman Co., Inc. · Aug 1986
ACROMED CANCELLOUS BONE SCREW
K860017 · Buckman Co., Inc. · Feb 1986
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983
SEIDEL INTRAMEDULLARY PLUG
K792205 · Howmedica Corp. · Dec 1979
HERBERT BONE SCREW
K792022 · Zimmer, Inc. · Oct 1979