Cleared Traditional

K880414 - TENDON HARVESTER

K880414 is an FDA 510(k) clearance for TENDON HARVESTER, manufactured by Concept, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K880414 · Concept, Inc. · Orthopedic device
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Mar 1988
Decision
53d
Days
Class 2
Risk

K880414 is an FDA 510(k) clearance for the TENDON HARVESTER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on March 25, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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 Concept, Inc. devices

FDA 510(k) Submission Details - K880414

510(k) Number K880414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1988
Decision Date March 25, 1988
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.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - HRX Arthroscope

All 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K880414.
28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES
K881715 · KARL STORZ Endoscopy-America, Inc. · Aug 1988
3M CARPAL TUNNEL
K881703 · 3M Company · Jul 1988
HERMAN CANNULA SET
K880203 · Orthopedic Systems, Inc. · Apr 1988
MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG
K874911 · Walter Lorenz Surgical, Inc. · Feb 1988
ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG
K873331 · Directed Energy, Inc. · Feb 1988
EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES
K880205 · Baxter Healthcare Corp · Feb 1988