Cleared Traditional

K923069 - RESTORE TUNNEL PLUG

K923069 is an FDA 510(k) clearance for RESTORE TUNNEL PLUG, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 348-day FDA review.

K923069 · Depuy, Inc. · Orthopedic device
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Jun 1993
Decision
348d
Days
Class 2
Risk

K923069 is an FDA 510(k) clearance for the RESTORE TUNNEL PLUG. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 8, 1993 after a review of 348 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K923069

510(k) Number K923069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date June 08, 1993
Days to Decision 348 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
226d slower than avg
Panel avg: 122d · This submission: 348d
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 543
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K923069.
CLARUS SERIES 2100 ENDOSCOPE
K923514 · Clarus Medical Systems, Inc. · Jan 1994
SYMBIOSIS REUSABLE ARTHROSCOPIC SURGICAL INST.
K924016 · Symbiosis Corp. · Dec 1993
DANEK TISSUE CUTTING AND REMOVAL SYSTEM
K922486 · Sofamor Danek Mfg., Inc. · Oct 1993
BURTON H- BASE TABLE - MODEL 1990
K924773 · R.H. Burton Co. · Jun 1993
ACUFEX T-BAR
K925573 · Acufex Microsurgical, Inc. · May 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · Davol, Inc. · Apr 1993