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) Official FDA 510(k) Summary (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.

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 684
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K060198.
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
ATHROCARE TOPAZ ARTHROWANDS
K053567 · Arthrocare Corp. · Mar 2006
DISC-FX SYSTEM
K052241 · Ellman International, Inc. · Feb 2006
ENDIUS ATAVI SYSTEM
K053267 · Endius, Inc. · Jan 2006
K060198 · MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
Download PDF FDA Summary Linvatec Corp.