STRYKER KNIFELIGHT

K961122 · Stryker Instruments · FTD · Aug 22, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961122
• Device Name: STRYKER KNIFELIGHT
• Applicant: Stryker Instruments
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Aug 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.

Device Story

Manual surgical instrument; sterile, single-use, disposable ligament/tissue release knife. Features integrated light source for site illumination; integral protective retractors for tissue protection. Used in surgical settings by physicians for minimally open procedures (e.g., carpal tunnel release). Provides improved visualization in restricted-view areas; facilitates ligament/tissue division via blade and optional standard elevator. Benefits include minimal disturbance of surrounding tissue and enhanced surgical site visibility.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical knife; integrated light source; integral protective retractors; optional standard elevator. Sterile, single-use, disposable device.

Indications for Use

Indicated for patients undergoing minimally open surgical release of ligaments or tissues, including carpal tunnel ligament release. Intended to improve visualization of carpal ligament, median nerve, and functional ligaments/tendons in restricted view areas.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Reference Devices

• Biomet (unspecified)
• Medtronic (unspecified)

Submission Summary (Full Text)

{0}

AUG 22 1955

510K Summary

k961122

## Device Name:

Classification Name: Surgical Knife, 79 EMF, Class I Surgical Instrument Light, 79 FSQ, Class II

Common/Usual Name: Lighted Knife

Proprietary Name: Stryker Knifelight

## Device Sponsor:

Stryker Corporation
Instruments Division
4100 East Milham Avenue
Kalamazoo, MI 49001
Registration No: 1811755

Regulatory Class: Class II

## Summary of Safety and Effectiveness:

The Stryker Knifelight is a manual surgical instrument used for the release of ligaments or other tissue including, but not limited to, the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site. The Stryker Knifelight allows for a minimally open technique with minimal disturbance of surrounding tissue.

The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The light source is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the surgical blade has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. A standard elevator may be available with the device to facilitate ligament or tissue division.

{1}

The Stryker Knifelight is equivalent to existing marketed products by companies such as Biomet and Medtronic. Intended use, function, and safety risks are all substantially equivalent.

The Stryker Knifelight does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker Knifelight is substantially equivalent to these existing devices.

Diane Davis
Regulatory Affairs Representative
Stryker Instruments