Question 1

Who is the manufacturer of HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.?

Accepted Answer

Howmedica Corp. filed the 510(k) submission for HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. (K872735).

Question 2

What is the FDA product code for HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.?

Accepted Answer

HSX. It is classified under 21 CFR 888.3520 as a Class 2 device in the Orthopedic panel.

Question 3

When was HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. cleared by the FDA?

Accepted Answer

Aug 4, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K872735
Device Name	HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.
Applicant	Howmedica Corp.
Product Code	HSX · Orthopedic
Decision Date	Aug 4, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3520
Device Class	Class 2

HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS.

Device Facts

Regulatory Classification

Identification