(287 days)
No
The summary describes a physical implant made of bone cement and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is clearly indicated for use as a temporary total knee replacement for patients undergoing a medical procedure due to a septic process, which aligns with the definition of a therapeutic device.
No
This device is a temporary total knee replacement used in a two-stage procedure for septic processes, not for diagnosing conditions. Its primary function is to replace, not to detect or monitor disease.
No
The device description clearly states that the device is a physical implantable component made of gentamicin/polymethylmethacrylate (PMMA) bone cement, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Spacer-K is a temporary total knee replacement for patients undergoing a two-stage procedure due to a septic process. This is a surgical implant used in vivo (within the body) to replace a joint.
- Device Description: The description confirms it's a temporary device mimicking a total knee prosthesis, composed of bone cement. This is a physical implant.
- 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. Spacer-K does not perform any such tests on samples.
Therefore, Spacer-K is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Product codes
JWH
Device Description
The Spacer-K is a temporary device that mimics a "total knee prosthesis". The twocomponent unconstrained design incorporates a femoral and a tibial component. The device is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The device is supplied sterile to an assurance level (SAL) of 10-6
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K03>522
page 17
2320 NW 66TH COURT GAINESVILLE, FL 32653
352-377-1140 FAX 352-378-2617
MAY 2 8 2004
Exactech
.
Tecres Spacer-K
Summary of Safety and Effectiveness Traditional 510(k)
| Applicant/ Consultant: | Exactech ® Inc.
2320 N.W. 66th Court
Gainesville, Florida 32653 |
|-------------------------|-----------------------------------------------------------------------|
| | Phone: (352) - 377 - 1140 |
| | Fax: (352) - 378 - 2617 |
| | Contact: Gary J. Miller, Ph.D.
Exec. V.P. of R&D |
| Manufacturer/Submitter: | Tecres S.p.A
FDA Owner/Operator ID# 9033624 |
Date:
May 19, 2004
rev. 05 19 04
..............................................................................................................................................................................
Section 4 Page 1 of 3
1
Ko)x-22 page 2
- Exactech
2320 NW 661H COURT GAINESVILLE, FL 32653
352-377-1140 FAX 352-378-2617
Tecres Spacer-K
Summary of Safety and Effectiveness Traditional 510(k)
Classifications / Proprietary Names:
| Classification Name: | Knee joint, femoral and tibial components,
polymeric, cemented |
|----------------------------------|-------------------------------------------------------------------|
| Product code: | JWH |
| C.F.R. Section: | 888.3560 |
| Device Class: | II |
| Classification Panel: | Orthopaedic |
| Trade / Proprietary Model Names: | Spacer-K
Temporary Knee Prosthesis |
Legally Marketed Device for Substantial Equivalence Comparison:
The Spacer-K device is substantially equivalent to the "Natural Knee". The device was cleared for marketing through premarket submission #K936159.
| Model | Manufacturer | 510(k) Number |
|---|---|---|
| Natural Knee | Centerplus | |
| (Sulzer, Intermedics) | #K936159 |
Device Description:
The Spacer-K is a temporary device that mimics a "total knee prosthesis". The twocomponent unconstrained design incorporates a femoral and a tibial component. The device is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) bone cement. The device is supplied sterile to an assurance level (SAL) of 10-6
rev. 05 19 04
2
K03r522 pg. 173
Image /page/2/Picture/1 description: The image shows the word "Exactech" in white letters against a black background. To the left of the word is a white dot. The font is bold and sans-serif.
2320 NW 66TH COURT GAINESVILLE, FI 32653
Tecres Spacer-K
352.377-1140 FAX 352-378-2617
Summary of Safety and Effectiveness Traditional 510(k)
INDICATIONS FOR USE
Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
CONTRAINDICATIONS
Use of Spacer-K is contraindicated in the following situations:
- ﺪ The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased 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 ﮯ apparatus and extensor mechanism.
- The procedure is unjustified due to deficiencies in the patient's muscular, nervous or » vascular systems.
- ﻴ Poor bone quality (as in osteoporosis) could cause the prosthesis to migrate or to fracture host bonc.
- Infection of the TKR cannot be confirmed. -
- The infected TKR devices cannot be removed. .
- The infecting pathogens are resistant to gentamicin. r
- The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone : cement.
- A systemic or secondary remote infection is suspected 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 joint. •
- The patient's weight, age or activity level would cause the surgeon to expect early failure of the system.
rev. 05 19 04
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the logo.
Public Health Service
MAY 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Simpson Senior Regulatory Representative Exactech. Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K032522
Trade/Device Name: Spacer-K Temporary Knee Prosthesis Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis --Regulatory Class: II Product Code: JWII Dated: March 4, 2004
Dear Ms. Simpson:
Received: March 5, 2004
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 for ass range ior 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Lisa Simpson
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will and w you to ought mains of substantial equivalence of your device to a legally prematicated predicated. " 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 acripliance at (301) 594-4639. 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 may be obtained from the 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/dsma/dsmamain.html
Sincerely yours,
Mark N Millkern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: #K032522
Spacer-K Temporary Knee Prosthesis Device Name:
INDICATIONS FOR USE
Spacer-K is indicated for use as a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is only indicated for an implantation period of 180 days or less. Because of the inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), Spacer-K is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
CONTRAINDICATIONS
Use of Spacer-K is contraindicated in the following situations:
- The patient's condition is such that a two-stage arthroplasty procedure is contraindicated due to decreased 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.
- 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. ﮯ
- The patient is sensitive (allergic) to gentamicin, aminoglycosides or PMMA bone cement.
- A systemic or secondary remote infection is suspected 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 joint.
- The patient's weight, age or activity level would cause the surgeon to expect early failure of the system.
Prescription Use X or Over the Counter Use No
Mark N. Milkerson
(Division Sign-Off)
Please do not write below this line - use another page if needed.
Division of General, Restorative,rence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
510(k) Number K032522