Cleared Traditional

K981636 - INTEGRATED DRIVE/PUMP SYSTEM

K981636 is an FDA 510(k) clearance for INTEGRATED DRIVE/PUMP SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K981636 · Linvatec Corp. · Orthopedic device
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Aug 1998
Decision
104d
Days
Class 2
Risk

K981636 is an FDA 510(k) clearance for the INTEGRATED DRIVE/PUMP SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 104 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 Linvatec Corp. devices

FDA 510(k) Submission Details - K981636

510(k) Number K981636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date August 20, 1998
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K981636.
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · Electro-Biology, Inc. · Oct 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · Stryker Endoscopy · Oct 1998
HYDROCISION ARTHROJET SYSTEM
K982266 · Hydrocision, Inc. · Sep 1998
MYELOTEC VIDEO GUIDED CATHETER
K980734 · Myelotec, Inc. · Aug 1998
KYPHON INFLATABLE BONE TAMP
K981251 · Kyphon, Inc. · Jul 1998
UNIVERSAL DRIVE SYSTEM
K981269 · Linvatec Corp. · Jun 1998