Cleared Traditional

K894719 - CYPRESS MEDICAL BONE SCREW & PLATES

K894719 is an FDA 510(k) clearance for CYPRESS MEDICAL BONE SCREW & PLATES, manufactured by Cypress Medical Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K894719 · Cypress Medical Mfg., Inc. · Orthopedic device
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Oct 1989
Decision
88d
Days
Class 2
Risk

K894719 is an FDA 510(k) clearance for the CYPRESS MEDICAL BONE SCREW & PLATES. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Cypress Medical Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on October 20, 1989 after a review of 88 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.

FDA 510(k) Submission Details - K894719

510(k) Number K894719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date October 20, 1989
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 1058
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K894719.
DEPUY (TM) TRUE COMPRESSION SCREW
K895389 · Depuy, Inc. · Nov 1989
CROSS CANCELLOUS BONE SCREW
K896044 · Buckman Co., Inc. · Nov 1989
ASNIS II GUIDED BONE SCREW
K895766 · Howmedica Corp. · Nov 1989
CORTICAL SCREW
K895217 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM
K895218 · Orthopedic Systems, Inc. · Sep 1989
CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
K895219 · Orthopedic Systems, Inc. · Sep 1989
K894719 · CYPRESS MEDICAL BONE SCREW & PLATES
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