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
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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.

View all Efs Eberle Feinwerktechnische Systeme devices

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
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 470
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K061134.
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K060198 · Linvatec Corp. · May 2006
ATHROCARE TOPAZ ARTHROWANDS
K053567 · Arthrocare Corp. · Mar 2006