DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES

K050210 · Biomet, Inc. · JWH · Jul 19, 2005 · Orthopedic

Device Facts

• Record ID: K050210
• Device Name: DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
• Applicant: Biomet, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Biomet disposable cement spacer molds is to provide the surgeon with a means to mold a temporary knee prosthesis at the point of care that is substantially equivalent to the Exactech Spacer-k temporary knee prosthesis cleared in K032522. The temporary knee prosthesis made with the Biomet disposable cleared in R0325221. The same indication for use as the Exactech Spacer-k.

Device Story

Disposable silicone molds used at point-of-care by surgeons to create temporary knee prosthesis components. Process involves filling molds with PMMA/gentamicin bone cement via dispenser/gun or pouring; cement hardens within mold; temporary prosthesis removed and implanted into joint space during first stage of two-stage TKR procedure. Device remains in situ for up to 180 days until second-stage implantation of conventional prosthesis. Benefits include temporary joint stabilization and local antibiotic delivery for patients with septic TKR. Surgeon manages entire workflow; device is not implanted itself.

Clinical Evidence

No clinical testing was performed. Evidence is based on bench testing, including knee joint simulator studies comparing the Biomet-molded temporary prosthesis to the predicate device, demonstrating equivalent strength, wear, and gentamicin elution.

Technological Characteristics

Medical grade silicone molds; femoral and tibial configurations in various sizes. Principle of operation: manual casting of PMMA/gentamicin bone cement. Non-implanted, sterile, disposable. No electronic components or software.

Indications for Use

Indicated for skeletally mature patients undergoing a two-stage total knee replacement (TKR) process due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Contraindicated for patients with systemic clinical conditions precluding two-stage arthroplasty, inadequate bone stock/support, deficient peripheral ligamentous/extensor mechanism, muscular/nervous/vascular deficiencies, poor bone quality (osteoporosis), unconfirmed TKR infection, non-removable infected TKR, gentamicin-resistant pathogens, sensitivity to gentamicin/aminoglycosides/PMMA, systemic/remote infection, infection secondary to trauma/other surgery, neuromuscular disorders, or patient factors (age/weight/activity) predicting early system failure.

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

• Exactech Spacer-k temporary knee prosthesis (K032522)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 1 9 2005

## 510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

- Contact Person: Lonnie Witham Telephone: [phone] Fax: [phone]
Proprietary Name: Disposable Cement Spacer Molds for Temporary Knee Prosthesis

Common Name: Bone Cement Spacer Mold

Classification Name: Knee joint, patellofemorotibial, polymer/metal/polymer, semiconstrained, cemented prosthesis (21 CFR 888.3560)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Eogany Marriousary Knee Prosthesis cleared by the FDA in K032522 and marketed by Exactech, Inc., Gainesville, FL.

Device Description: The femoral cement spacer molds are offered in four sizes (60mm, 65mm, 70mm & 75mm). The tibial cement spacer molds are offered in four sizes (65mm, 70mm, 75mm & 80mm). The disposable cement spacer molds are not implanted. (Osmith, Tonin, Tonin Conethylmethacrylate /gentamicin bone cement, or equivalent, either by injecting with a dispenser/gun, or by pouring the prepared cement into the mold. enther by mjocant hardens, the temporary knee prosthesis components are removed from Aner the ochlent and placed into the joint space. The temporary knee prosthesis remains in place the mores and played the second stage of the two-stage procedure is performed to implant a conventional knee joint prosthesis.

Intended Use: The intended use of the Biomet disposable cement spacer molds is to provide the surgeon with a means to mold a temporary knee prosthesis at the point of care that is substantially equivalent to the Exactech Spacer-k temporary knee prosthesis cleared in K032522. The temporary knee prosthesis made with the Biomet disposable cleared in R0325221. The same indication for use as the Exactech Spacer-k.

Indication for Use: Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a twotemporary total the replaceting process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (polymethylmethacrylate/gentamicin), the molded temporary prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

{1}------------------------------------------------

## Contraindications:

The temporary knee prosthesis made with the disposable cement spacer molds is contraindicated for the following situations:

- ndreated is to 's condition is such that a two-stage arthroplasty procedure is . I he patient's contrasted immune response or other relevant systemic clinical conditions.
- Bone loss precluding adequate support of the prosthesis. .
- Lack of adequate competence (anatomical and functional) of peripheral . ligamentous apparatus and extensor mechanism.
- The procedure is unjustified due to deficiencies in the patient's muscular, nervous . or vascular systems.
- or vasural by title . fracture host bone.
- Infection of the TKR cannot be confirmed. .
- The infected TKR devices cannot be removed. .
- The infecting pathogens are resistant to gentamicin. .
- The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone . cement.
- A systemic or secondary remote infection is expected or confirmed. .
- The patient does not have a TKR and the infection is secondary to trauma, septic . arthritis or other surgical procedures.
- The patient does not have sufficient bone stock to allow insertion and fixation of . the prosthesis.
- The patient has neuromuscular disorders that do not allow control of the knee . ioint.
- Joins.
The patient's age, weight, or activity level would cause the surgeon to expect . early failure of the system.

Summary of Technologies: The bone cement molds (femoral and tibial) are sterile disposables made of medical grade silicone. The disposable cement spacer molds produce temporary knee prosthesis components that are composed of similar bone cement in similar sizes as the predicate.

Non-Clinical Testing: Comparative testing was performed utilizing a knee joint Nor. Onlined. 16 both the temporary knee prosthesis made with the Biomet disposable cement sumulator of oour the Exactech Spacer-K device. The temporary knee prostheses were spacer mbe equivalent in strength and wear characteristics. Elution testing demonstrated equivalent gentamicin release.

Clinical Testing: No clinical testing was performed.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lonnie Witham Biomet, Inc. 56 East Bell Drive Warsaw, Indiana 46581

Re: K050210

K030210
Trade/Device Name: Disposable Spacer Molds for Temporary Knee Prosthesis Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 30, 2005 Received: July 1, 2005

Dear Mr. Witham:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 rots) premained is substantially equivalent (for the indications ferenced and nave decembined the are are are are are are and see marketed in interstate for use stated in the encrosule for tegally manaties provice Americal Device Ameral Read, Drug commerce prior to May 20, 1970, the encordance with the provisions of the Federal Food, Drug, devices that have been reciassince in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require special controls provisions of the Act. The You may, therefore, market the devices, boyer to the ments for annual registration, listing of general controls provisions of the rise, 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 classified (see above) into exist in the subs are of the device can
may be subject to such additional controls. Existing major regulations FDA may may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Pouchal Ing.
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 Please be advised that FDA 3 issualled of a backers of a backer requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a delorimiation administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CPR Part 807), labening (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

# Page 2 - Mr. Lonnie Witham

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manieting your and equivalence of your device to a legally prematicate 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 advice for your aconce to the 0.000. Also, please mote the regulation entitled, a Colliact the Office of Compuner of the (21CFR Part 807.97). You may obtain Misolalling by reference to premail.com bilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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: Disposable Cement Spacer Molds for Temporary Knee Prosthesis

## Indications For Use:

Indications For Use:
Disposable cement spacer mold a temporary total kneereduced van a sentic process. The molded Disposable cement spacer molds are nutleated to as wonedure due to a septic process. The molded for skeletally mature patients undergolity a two-stage prodot of 180 days of inherent
temporary knee prosthesis is indicated for an implantation period of 180 days of inheren temporary knee prosthesis is mulce material (gentamicin/polyombility), the molded
mechanical limitations of the device material (gentamicin/polyments), is a si mechanical limitations of the device material (gentainensportions) and mobility assist devices (e.g. crutches, walkers) throughout the implant period.

### Contraindications:

Contraindications:
The temporary knee prosthesis made with the disposable cement spacer molds is contraindicated for the following situations:

- ng situations:
The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to . I he patient's condition is sack and systemic clinical conditions.
- Bone loss precluding adequate support of the prosthesis.
- . Bone loss preciuding adequate support of the problemal) of peripheral ligamentous apparatus �
- and extensor mechanism. The procedure is unjustified due to deficiencies in the patient's muscular, nervous or vascular . systems.
- systems.
Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host . bone.
- Infection of the TKR cannot be confirmed. ●
- The infected TKR devices cannot be removed. .
- The infecting pathogens are resistant to gentamicin. .
- The intecting patiogens are resiblant to grain.
The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone cement. .
- I he pation is sensitere (remote infection is expected or confirmed.
- . A systemic of secondary renote infection is oxposited or collary to trauma, septic arthritis or other . surgical procedures.
- surgical procedures.
The patient does not have sufficient bone stock to allow insertion and fixation of the prosthesis.
- . The patient has neuromuscular disorders that do not allow control of the knee joint.
- . I he patient's age, weight, or activity level would cause the surgeon to expect early failure of the . system.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

2

Concurrence of CDRH, Office of Device Evaluation (ODE)

8050210

iriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

Page 1 of 1

510(k) Number --