P.F.C. SIGMA INSET PATELLA

K971652 · Johnson & Johnson Professionals, Inc. · JWH · Jul 16, 1997 · Orthopedic

Device Facts

• Record ID: K971652
• Device Name: P.F.C. SIGMA INSET PATELLA
• Applicant: Johnson & Johnson Professionals, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The P.F.C.® Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

Device Story

P.F.C. Sigma Inset Patella is a semi-constrained total knee prosthesis component used in total knee replacement surgery. Constructed of UHMWPE, the device is implanted into a reamed cavity in the patella and fixed using PMMA bone cement. It features a 1-inch spherical radius articulating surface, dovetail undercut cement pockets, and round/clover peg geometry. The device is intended for use by orthopedic surgeons in a clinical/OR setting to restore joint function and alleviate pain in patients with severe structural knee damage. It serves as a replacement component within the P.F.C. Sigma Knee System, providing a stable articulating surface against the femoral component.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: UHMWPE. Fixation: Cemented (PMMA). Design: Semi-constrained patellar prosthesis with 1-inch spherical radius articulating surface, dovetail undercut cement pockets, and round/clover peg geometry. Implantation requires reamed cavity preparation.

Indications for Use

Indicated for patients with severe pain and disability due to permanent structural damage from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma, or failed prior surgical intervention. Requires use with bone cement (PMMA).

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

• P.F.C.® Σ Oval Dome Patella (K961685)
• Universal Inset Patella (K933867)

Submission Summary (Full Text)

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Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham. MA 02767-0350

Contact Person: John Ferros Phone: [phone]

#### Name of Device

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87. Common Name: Semi-constrained total knee prosthesis.

Trade Name/Proprietary Name: P.F.C. Sigma Knee System Inset Patella

Performance Standards: No performance standards have been developed for this device.

### Predicate Device

P.F.C.® Σ Oval Dome Patella, Universal Inset Patella

# Description of Device

The P.F.C. Sigma Inset Patella is a patellar prosthesis intended for use in Total Knee Replacement. The device is constructed of UHMWPE.

# Intended Use

The P.F.C.® Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis,

osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

#### Technological Characteristics Compared to Predicate Device

| | P.F.C. Σ<br>Inset Patella<br>(subject of this submission) | P.F.C. Σ<br>Oval-Dome Patella<br>K961685 | Universal<br>Inset Patella<br>K933867 |
|------------------------------------|-----------------------------------------------------------|------------------------------------------|---------------------------------------|
| Design | | | |
| Bone Removal | reamed cavity | planar resection | reamed cavity |
| Bone Periphery @ Major<br>Diameter | yes | no | yes |
| Articulating Surface | 1" spherical radius¹ | 1" spherical radius¹ | 0.8" spherical radius² |
| Cement Pocket Geometry | Dovetail Undercut | Dovetail Undercut | Dovetail Undercut |
| Peg Geometry(ies) | Round & Clover | Round | Round |
| Material | UHMWPE | UHMWPE | UHMWPE |

Exactly matches the PFC® Σ Femur (C/R, C/S & TC3) Patellar Grooves 1.

Approximately matches the PFC® C/R Femur Patellar Groove 2.

Image /page/0/Picture/20 description: The image shows the number 10 written in a handwritten style. The number is written in black ink on a white background. The number is slightly tilted to the left.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John D. Ferros Senior Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

JUL 16 1997

Re : K971652 P.F.C.® Σ (Sigma) Inset Patella Requlatory Class: II Product Code: JWH Dated: May 5, 1997 Received: May 6, 1997

Dear Mr. Ferros:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

- 1. This device may not be labeled or promoted for non-cemented use.
- All labeling for this device, including package 2. label and labeling included within the package, must prominently state that the device is intended for cemented use only.

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- Any non-cemented fixation of this device is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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Page 3 - Mr. John D. Ferros

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: P.F.C. Sigma Knee System Inset Patella

Indications for Use:

The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use _x (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)