Cleared Traditional

K843370 - IMSI/METRIPOND GRIPPER PLATE

K843370 is an FDA 510(k) clearance for IMSI/METRIPOND GRIPPER PLATE, manufactured by Intl. Management Services, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K843370 · Intl. Management Services, Inc. · Orthopedic device
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Jan 1985
Decision
148d
Days
Class 2
Risk

K843370 is an FDA 510(k) clearance for the IMSI/METRIPOND GRIPPER PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Intl. Management Services, Inc. (Lincoln, US). The FDA issued a Cleared decision on January 23, 1985 after a review of 148 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Management Services, Inc. devices

FDA 510(k) Submission Details - K843370

510(k) Number K843370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date January 23, 1985
Days to Decision 148 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
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 1257
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K843370.
LETOURNEL ACETABULAR PLATE
K850401 · Pfizer, Inc. · Apr 1985
MEC BROAD BONE PLATE
K850442 · Pfizer, Inc. · Apr 1985
MEC BUTRESS PLATE
K850444 · Pfizer, Inc. · Apr 1985
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · Synthes (Usa) · May 1984
ACE BROOKER BONE PLATING SYSTEM
K833865 · Buckman Co., Inc. · Dec 1983
CRYOPHTHALMIC UNIT
K811244 · Keeler Instruments, Inc. · Jun 1981