Cleared Special

K060198 - MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

K060198 is an FDA 510(k) clearance for MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Special 510(k) pathway after a 105-day FDA review.

K060198 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
105d
Days
Class 2
Risk

K060198 is an FDA 510(k) clearance for the MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, .... Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 11, 2006 after a review of 105 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K060198

510(k) Number K060198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2006
Decision Date May 11, 2006
Days to Decision 105 days
Submission Type Special
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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

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 520
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K060198.
CONMED LINVATEC 24K IRRIGATION SYSTEM
K063326 · Conmed Linvatec · Jan 2007
SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM
K062849 · Smith & Nephew, Inc. · Jan 2007
MODIFICATION TO ENDIUS ATAVI SYSTEM
K061345 · Endius, Inc. · Jun 2006
ATHROCARE TOPAZ ARTHROWANDS
K053567 · Arthrocare Corp. · Mar 2006
ENDIUS ATAVI SYSTEM
K053267 · Endius, Inc. · Jan 2006
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
K051656 · Osteobiologics, Inc. · Oct 2005