KASM KNEE ARTICULATING SPACER MOLDS

• K Number: K133449
• Device Name: KASM KNEE ARTICULATING SPACER MOLDS
• Manufacturer: ORTHO DEVELOPMENT CORP.
• Date Cleared: 2014-02-18 ( 98 days)
• Product Code: JWH MBB
• Regulation Number: 888.3560

Intended Use

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications: 1. Active sepsis which requires a two-stage revision arthroplasty procedure 2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period 3. Implantation period of 180 days or less Use only with polymethylmethacrylate/gentamicin bone cement. The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Device Description

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

Predicate Devices

K050210

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and function of the molds used to create a temporary knee prosthesis, with no mention of AI or ML technologies.

Therapeutic

Yes.
The KASM® is used in temporary total knee arthroplasty procedures as a mold to create an articulating cement spacer prosthesis, which serves as a temporary knee prosthesis during the first stage of a two-stage revision knee arthroplasty, and also contains gentamicin for active sepsis.

Diagnostic

No

KASM® is a medical device used to create a temporary knee prosthesis (spacer) during a two-stage revision knee arthroplasty, not for diagnosing a condition. Its function is to facilitate the surgical procedure and provide a temporary mechanical support and antibiotic delivery, as explicitly stated in "Intended Use" and "Device Description" sections.

SaMD (Software as a Medical Device)

No

The device description clearly states that KASM® knee articulating spacer molds are comprised of a physical material (thermoplastic urethane) and are single-use molds. This indicates a physical hardware component, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
• KASM®'s Function: KASM® is a mold used during surgery to create a temporary knee prosthesis (a cement spacer) that is implanted into the patient's knee joint. It is a surgical device, not a device used for testing samples outside the body.
• Intended Use: The intended use clearly describes a surgical procedure for temporary total knee arthroplasty.
• Device Description: The description details a mold used to fashion an implantable device.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory results.

Therefore, KASM® falls under the category of a surgical implant or a device used in a surgical procedure, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

1. Active sepsis which requires a two-stage revision arthroplasty procedure
2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period
3. Implantation period of 180 days or less
   Use only with polymethylmethacrylate/gentamicin bone cement.
   The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Product codes (comma separated list FDA assigned to the subject device)

JWH, MBB

Device Description

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee

Indicated Patient Age Range

Skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:
Property: Gentamicin Elution Rate Study
Result: Substantially equivalent antibiotic elution rate as compared to cement manufacturer's reported elution rate
Property: Tibial Mechanical Strength
Result: Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Property: Tibial Fatigue Strength
Result: Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Property: Cement Spacer Wear Study
Result: Substantially equivalent to StageOne™
*test adapted from ISO 14243

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

StageOne™ Knee Cement Spacer Molds, Biomet (K050210)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
Classification. Class II.

Summary

0

FEB 1882014

Section 5

510(k) Summary

| NAME OF SPONSOR: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Mike Ensign
Director of Regulatory Affairs and Quality Assurance
Telephone: [phone]
Facsimile: [phone]
Email: [e-mail] |
| DATE PREPARED: | October 30, 2013 |
| PROPRIETARY NAME: | KASM® Knee Articulating Spacer Molds |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3560, Knee joint, patellofemorotibial,
polymer/metal/polymer semi-constrained cemented prosthesis |
| DEVICE PRODUCT CODES: | JWH, MBB |
| PREDICATE DEVICES: | StageOne™ Knee Cement Spacer Molds, Biomet (K050210) |

1

Device Description

KASM® knee articulating spacer molds include two single-use molds: one tibial and one femoral. Both molds are comprised of a translucent, firm but flexible USP class VI medical-grade thermoplastic urethane. Multiple sizes are offered for both the femoral and tibia! KASM® molds, in order to accommodate a wide range of patient anatomies. The femoral and tibial molds are to be used in the first stage of a two-stage revision knee arthroplasty. The KASM® knee articulating spacer molds are designed to facilitate a surgeon to intraoperatively fashion a polymethylmethacrylate (PMMA) articulating cement spacer (both femoral and tibial components) which contains gentamicin that will serve as a temporary knee prosthesis for an implantation period not to exceed 180 days. The KASM® cement spacers are for cemented use only.

Indications for Use

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

• 1. Active sepsis which requires a two-stage revision arthroplasty procedure
• 2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, canes, crutches, etc., for the entire implantation period
• 3. Implantation period of 180 days or less

Use only with polymethylmethacrylate/gentamicin bone cement.

The articulating cement spacer prosthesis fashioned using the KASM® mold is intended for cemented fixation only.

Technological Characteristics

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There are two differences between the KASM® cement spacer molds and its predicate, the StageOne™ Knee Cement Spacer Molds. First, KASM® molds are fabricated using Pellethane, a medical-grade thermoplastic urethane; StageOne™ Knee Cement Spacer Molds are fabricated from a medical-grade silicone elastomer. Second, the KASM® femoral mold is designed as an open-faced mold to be filled and placed in situ allowing the cement spacer to cure in place in a single step; the StageOne™ femoral mold is designed as a fully enclosed mold that must be filled utilizing a pressurized cement injector system. Once cured, the StageOne™ femoral cement spacer mold is torn open and the released femoral cement spacer is affixed to patient anatomy using a second bone cement curing step.

2

The KASM® and StageOne™ tibial spacer molds are used in an identical fashion; both molds are openfaced and intended to be filled to the desired thickness, allowed to cure, then affixed to patient anatomy using a second bone cement curing step.

Performance Data

The following non-clinical testing was performed to determined substantial equivalence to the predicate devices:

Property	Result
Gentamicin Elution Rate Study	Substantially equivalent antibiotic elution rate as compared to cement manufacturer's reported elution rate
Tibial Mechanical Strength	Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Tibial Fatigue Strength	Substantially equivalent to StageOne™ tibial cement spacer
*test adapted from ASTM F1800
Cement Spacer Wear Study	Substantially equivalent to StageOne™
*test adapted from ISO 14243

Basis for Substantial Equivalence

• This 510(k) demonstrates that the KASM® femoral and tibial cement spacer molds are substantially equivalent to the previously cleared predicate device based on similarities in intended use, design, materials, and mechanical performance.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The logo is in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2014

Ortho Development Corporation Mr. Mike Ensign Director of Regulatory Affairs and Quality Assurance 12187 South Business Park Drive Draper, Utah 84020

Re: K133449

Trade/Device Name: KASM® Knee Articulating Spacer Molds Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II Product Code: JWH, MBB Dated: January 3, 2014 Received: January 7, 2014

Dear Mr. Ensign:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

4

Page 2 - Mr. Mike Ensign

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Lori A. Wigqins

• for
  Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

'DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133449

Device Name

KASM® Knee Articulating Spacer Molds

Indications for Use (Describe)

KASM® is intended for use in temporary total knee arthroplasty procedures with the following indications:

1. Active sepsis which requires a two-stage revision arthroplasty procedure

2. Skeletally mature patients who will consistently use limited mobility assistive devices such as a walker, clos, for the entire implantation period

3. Implantation period of 180 days or less

Use only with polymethylmethacrylate/gentamicin bone cement.

The articulating cement spacer prosthesis fashioned using the KASM® mold is intended fixation only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Laurence D. Coyne -S

(Division Sign-Off)

Division of Orthopedic Devices

510(k) Number: K133449

FORM FDA 3881 (9/13)

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