Cleared Traditional

K061134 - EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES

K061134 is an FDA 510(k) clearance for EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES, manufactured by Efs Eberle Feinwerktechnische Systeme. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K061134 · Efs Eberle Feinwerktechnische Systeme · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
130d
Days
Class 2
Risk

K061134 is an FDA 510(k) clearance for the EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Efs Eberle Feinwerktechnische Systeme (Ft. Lauderdale, US). The FDA issued a Cleared decision on September 1, 2006 after a review of 130 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K061134

510(k) Number K061134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2006
Decision Date September 01, 2006
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 648
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K061134.
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
X-STEN MILD TOOL KIT, MODEL MTK-0001
K062038 · X-Sten Corp. · Dec 2006
FLOSIMPLE ARTHROSCOPY PUMP A120
K062380 · W.O.M. World of Medicine AG · Dec 2006
ENDOSCOPIC SPINE SYSTEM
K061246 · Arthro Kinetics, Inc. · Aug 2006
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · Endius, Inc. · Jun 2006
REMA SHAVER BLADES
K060172 · Rema Medizintechnik GmbH. · May 2006
K061134 · EBERLE SHAVER SYSTEM C2 AND SHAVER BLADES
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