What is the FDA product code for SMITH & NEPHEW GENESIS II DEEP FLEXION 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 SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT?

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

What are the predicate devices for SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT?

Genesis II Total Knee System (K951987); Genesis II Total Knee System (K953274); Genesis II Total Knee System (K030612).

Who can help prepare an FDA 510(k) submission like SMITH & NEPHEW GENESIS II DEEP FLEXION 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.

SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT

Q: Who is the manufacturer of SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT?

Smith & Nephew, Inc. filed the 510(k) submission for SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT (K041825).

K041825 · Smith & Nephew, Inc. · JWH · Mar 11, 2005 · Orthopedic

Device Facts

Record ID	K041825
Device Name	SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
Applicant	Smith & Nephew, Inc.
Product Code	JWH · Orthopedic
Decision Date	Mar 11, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3560
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System. The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative 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 Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System. The Genesis II Total Knee System is indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative 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. It where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee pattern cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only.

Device Story

Genesis II Deep Flexion Cruciate Retaining Articular Insert; UHMWPE tibial component; used with Genesis II Total Knee System components (cemented or porous/uncemented). Enables greater flexion range for patients with anatomical capability. Single-use device; implanted by orthopedic surgeons in clinical/hospital settings. Provides articular surface for knee joint; facilitates joint motion; supports long-term knee function. Benefits include improved range of motion for eligible patients.

Clinical Evidence

Bench testing only. Mechanical test data indicates the device is equivalent to currently used clinical devices and capable of withstanding expected in vivo loading without failure.

Technological Characteristics

UHMWPE tibial component; semi-constrained; designed for use with Genesis II Total Knee System femoral, tibial tray, and patellar components. Single-use.

Indications for Use

Indicated for rheumatoid, post-traumatic, or degenerative arthritis in older patients with compatible age, weight, and activity levels; failed osteotomies; unicompartmental or total knee replacement. Posterior stabilized systems indicated for primary/revision surgery where anterior/posterior cruciate ligaments are absent/incompetent and 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

Genesis II Total Knee System (K951987)
Genesis II Total Knee System (K953274)
Genesis II Total Knee System (K030612)

Reference Devices

Genesis II P/S High Flexion Articular Insert (K032295)

Related Devices

K032295 — GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT · Smith & Nephew, Inc. · Aug 21, 2003
K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT · Stelkast Company · Jan 18, 2007
K042515 — SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE · Smith & Nephew, Inc. · Mar 14, 2005
K051229 — PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT · Smith & Nephew, Inc. · Jul 20, 2005
K033890 — ADVANCE DOUBLE HIGH INSERT · Wrightmedicaltechnologyinc · Jan 15, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ K041825 p. 1/2 ## Smith & Nephew, Inc. Summary of Safety and Effectiveness Genesis II Deep Flexion Cruciate Retaining Articular Insert ### Contact Person and Address Date of Summary: July 6, 2004 Kim Kelly Project Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6566 W/R/1 2005 Name of Device: Genesis II Deep Flexion Cruciate Retaining Articular Insert Common Name: Articular insert ### Device Description The Genesis II Deep Flexion Cruciate Retaining Articular Inserts are UHMWPE tibial components which provide the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range. The insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274 or with the system's porous, uncemented femoral and tibial tray components cleared in K030612. | Identification of Device | Product Code | Classification Name | Code | Predicate 510(k) | Identification of Device | Indications for Use | Predicate 510(k) | |-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Genesis II Deep Flexion C/R Insert for use with Genesis II 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 | K951987 K953274 | Genesis II Deep Flexion C/R Insert for use with Genesis II Total Knee System Components in cemented applications | The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System. The Genesis II Total Knee System is indicated for rheumatoid arthritis; post- traumatic arthritis, osteoarthritis, or degenerative 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 Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented femoral, tibial tray, and patellar components of the Genesis II Total Knee System cleared via K951987 and K953274. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only. | K951987 K953274 | | Genesis II Deep Flexion C/R Insert for use with Genesis II 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 | K030612 | Genesis II Deep Flexion C/R Insert for use with Genesis II Total Knee System Components in uncemented applications | The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in conjunction with the components of the Genesis II Total Knee System. The Genesis II Total Knee System is indicated for rheumatoid arthritis; post- traumatic arthritis, osteoarthritis, or degenerative 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 Genesis II Deep Flexion Cruciate Retaining Articular Insert is used with existing cemented patellar and uncemented porous tibial trays and femoral components of the Genesis II Total Knee System cleared via K030612. The Genesis II Deep Flexion Cruciate Retaining Articular Insert is for single use only. | K030612 | ### Mechanical and Clinical Data A review of the mechanical test data indicated that the Genesis II Deep Flexion Cruciate Retaining Articular Insert is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure. {1}------------------------------------------------ # Indications for Use # Substantial Equivalence Information The substantial equivalence of the Genesis II Deep Flexion Cruciate Retaining Articular Insert is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Smith & Nephew's Genesis II Total Knee System (K951987, K953274, and K030612) and the Genesis II P/S High Flexion Articular Insert (K032295). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows a black and white logo. The logo is a circular seal with text around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread. The bird is facing to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 MAR 1 1 2005 Re: K041825 Trade/Device Name: Genesis II Deep Flexion Cruciate Retaining Articular Insert Regulation Number: 21 CFR 888.3560, 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: February 8, 2005 Received: February 9, 2005 Dear Mr. Sells: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {3}------------------------------------------------ ### Page 2 - Mr. Jason Sells CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IN Fart 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisting of substantial equivalence of your device to a legally premailted predicate 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 desire specific acrioliance at (240) 276-0120. Also, please note the regulation entitled, eonaler the Orition of Computible to the transmit (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international 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, Mack A. Millican Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K041525 p. 1/2 ### Indications for Use 510(k) Number (if known): Device Name: Genesis II Deep Flexion Cruciate Retaining Articular Insert Indications for Use: The Genesis II Deep Flexion Cruciate Retaining Articular Insert is intended to be used in the Genesis II Deep Flexion Cruciall Total Knoo System The Genesis II Beep Ronton Crain Crain Crain II Total Knee System. 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