Who is the manufacturer of PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

Smith & Nephew, Inc. filed the 510(k) submission for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT (K051229).

What is the FDA product code for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

JWH. It is classified under 21 CFR 888.3560 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

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

What are the predicate devices for PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

Profix Total Knee System (K933958); Profix Total Knee System (K030623).

Who can help prepare an FDA 510(k) submission like PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT?

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.

PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT

K051229 · Smith & Nephew, Inc. · JWH · Jul 20, 2005 · Orthopedic

Device Facts

Record ID	K051229
Device Name	PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
Applicant	Smith & Nephew, Inc.
Product Code	JWH · Orthopedic
Decision Date	Jul 20, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623).

Device Story

Profix Flex Cruciate Retaining Articular Insert is a UHMWPE tibial component for the Profix Total Knee System. Device functions as a bearing surface in total knee arthroplasty; replaces damaged joint surfaces to restore function and reduce pain. Used in clinical settings by orthopedic surgeons during primary or revision knee replacement procedures. Output is a physical implant component; provides mechanical stability and articulation for the knee joint. Benefits include improved joint mobility and long-term clinical outcomes for patients with degenerative joint disease or failed prior surgeries.

Clinical Evidence

Bench testing only. Mechanical test data indicates the device is capable of withstanding expected in vivo loading without failure.

Technological Characteristics

UHMWPE (Ultra-High Molecular Weight Polyethylene) tibial articular insert. Semiconstrained design. Single-use. Compatible with existing Profix Total Knee System metal/polymer components. No electronic or software components.

Indications for Use

Indicated for patients with rheumatoid arthritis, post-traumatic arthritis, or those requiring revision surgery due to failed osteotomies, unicompartmental replacement, or total knee replacement. Suitable for older patients with activity levels compatible with long-term results. Posterior stabilized systems are indicated for primary/revision surgery where anterior/posterior cruciate ligaments are absent/incompetent but collateral ligaments remain intact.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

Profix Total Knee System (K933958)
Profix Total Knee System (K030623)

Reference Devices

Genesis II Deep Flexion C/R Articular Insert (K041825)

Related Devices

K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT · Stelkast Company · Jan 18, 2007
K041591 — SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS · Howmedica Osteonics Corp. · Sep 23, 2004
K041825 — SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT · Smith & Nephew, Inc. · Mar 11, 2005
K030623 — SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM · Smith & Nephew, Inc. · May 22, 2003
K173875 — GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert · Stelkast, Inc. · Jan 19, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ JUL 20 2005 ## Smith & Nephew, Inc. Summary of Safety and Effectiveness Profix Flex Cruciate Retaining Articular Insert K051229 f 1/2 ### Date of Summary: May 12, 2005 Contact Person and Address Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 1901) 399-5520 # Name of Device: Profix Flex Cruciate Retaining Articular Insert Common Name: Articular insert Common Name: Anticular Insert Classification: 21 CFR 888.3560 (Knee joint patellofemorotibial polymer/metal/polymers/archmon ssification: 21 CFR 060.3500 (N) and 21 CFR 888.3565 (Knee joint patellofemorotibial metal/polyment porous-coated uncemented prosthesis - Class II) ## Device Description Device Deschiption The Profix Flex Cruciate Retaining Articular Inserts are UHMWPE tibial components which accommodate The Profix Flex Cruciate Relaining Antoclarines in Subscribers of Series flexion range. The greater lies on to those patiente with his and patellar components of the Profix Total Knee System cleared via K933958 (cemented use) and K030623 (uncemented use). ## Device Classification | Identification of Device | Product Code | Classification Name | Code | Predicate 510(k) | |------------------------------------------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------|---------------------| | Profix Flex CR insert for use with Profix Total Knee System Components in cemented applications | JWH- Orthopaedics Panel/87 | Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis - Class II | 21 CFR 888.3560 | K933958 | | Profix Flex CR insert for use with Profix Total Knee System Components in uncemented applications | MBH- Orthopaedics Panel/87 | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Class II | 21 CFR 888.3565 | K030623 | ## Mechanical and Clinical Data Mechanical and echanical test data indicated that the Profix Flex Cruciate Retaining Articular Insert is A review of the wices currently used clinically and is capable of withstanding expected in vivo loading without failure. ## Indications for Use indications for our our rolar Mod send with in older patients whose age, weight, and activity level are compatible with an degeneral vong -term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where r osterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. {1}------------------------------------------------ K051229 1/2 The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623). ## Substantial Equivalence Information The substantial equivalence of the Profix Flex CR Articular Insert is based on its similarities in indications for rine design features, operational principles, and material composition to the following predicate devices – aso, aborgh roaders, operation in provinces of the Genesis II Deep Flexion C/R Articular Insert (K041825). {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 0 2005 Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 \$\frac{1}{2}\$ Re: K051229 RoJ1229 Trade/Device Name: Profix Flex Cruciate Retaining Articular Insert Regulation Number: 21 CFR 888.3560, 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis, Knee joint patellofemorotibial metal/polymer porous- coated uncemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: July 14, 2005 Received: July 15, 2005 Dear Mr. Sells: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conninered prior to the) 2018 sified in accordance with the provisions of the Federal Food, DNA de vices that have occh reciasincat require approval of a premarket approval application (PMA). and Costine real (110.) that to hevice, subject to the general controls provisions of the Act. The r ou may, mererore, mains of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elassince (tional controls. Existing major regulations affecting your device can may or subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r louse of acrease a determination that your device complies with other requirements of the Act that I Dr has Intact a and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF It Fat 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and quinn ontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Jason Sells This letter will allow you to begin marketing your device as described in your Section 510(k) I mis iciter will anow you to organization of substantial equivalence of your device to a legally premaired predicated device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dome of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Signature Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Indications for Use 510(k) Number (if known): Device Name: Profix Flex Cruciate Retaining Articular Insert Indications for Use: Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, rolar Nrece components in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, computible intire and designed stabilized knee systems are designed for use in patients in or tolarwiso replacement. primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Profix Flex Cruciate Retaining (CR) articular insert is a single-use component intended to be used in conjunction with existing components of the Profix Total Knee System cleared for cemented use (K933958) or uncemented use (K030623). Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Enalin n of General, Restorative Ko51229 Page 1 of /