Cleared Traditional

K924016 - SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICA...

K924016 is an FDA 510(k) clearance for SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICA..., manufactured by Symbiosis Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 482-day FDA review.

K924016 · Symbiosis Corp. · Orthopedic device
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Dec 1993
Decision
482d
Days
Class 2
Risk

K924016 is an FDA 510(k) clearance for the SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on December 6, 1993 after a review of 482 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Symbiosis Corp. devices

FDA 510(k) Submission Details - K924016

510(k) Number K924016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1992
Decision Date December 06, 1993
Days to Decision 482 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 122d · This submission: 482d
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 K924016.
ARTHREX INSTRUMENTS ( HIP )
K926212 · Arthrex, Inc. · Jan 1994
ARTHREX INSTRUMENTS (WRIST)
K926303 · Arthrex, Inc. · Jan 1994
ACUFEX PRO-PAC AND ISO-PAC
K931621 · Acufex Microsurgical, Inc. · Jan 1994
RESTORE TUNNEL PLUG
K923069 · Depuy, Inc. · Jun 1993
ACUFEX T-BAR
K925573 · Acufex Microsurgical, Inc. · May 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · Davol, Inc. · Apr 1993