Cleared Abbreviated

K112548 - ALTOMEC ARTHROSCOPE

K112548 is an FDA 510(k) clearance for ALTOMEC ARTHROSCOPE, manufactured by Altomec Endoscopy, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Abbreviated 510(k) pathway after a 349-day FDA review.

K112548 · Altomec Endoscopy, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
349d
Days
Class 2
Risk

K112548 is an FDA 510(k) clearance for the ALTOMEC ARTHROSCOPE. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Altomec Endoscopy, Inc. (Chesterfield, US). The FDA issued a Cleared decision on August 15, 2012 after a review of 349 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K112548

510(k) Number K112548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date August 15, 2012
Days to Decision 349 days
Submission Type Abbreviated
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
227d slower than avg
Panel avg: 122d · This submission: 349d
Pathway characteristics
Standards-based clearance path.

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 646
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K112548.
VERTIFLEX DIRECT DECOMPRESSION SYSTEM
K122662 · Vertiflex, Inc. · Nov 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · Theken Spine, LLC · Aug 2012
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS)
K121548 · Spine View, Inc. · Aug 2012
ESPIN
K120553 · Nlt Spine, Ltd. · Aug 2012
ENSPIRE DISCECTOMY SYSTEM
K120680 · Spine View, Inc. · Jun 2012
TRANSCORP SPINAL ACCESS SYSTEM
K113352 · Transcorp, Inc. · Apr 2012
K112548 · ALTOMEC ARTHROSCOPE
Download PDF FDA Summary Altomec Endoscopy, In…