(207 days)
No
The description focuses on the physical components and intended use of a temporary hip prosthesis mold, with no mention of AI or ML technologies.
No.
The device is described as molds used to create a temporary cement spacer for a hemi-hip replacement in a two-stage revision procedure due to infection. While the temporary prosthesis molded by these devices contains an antibiotic and addresses a medical condition, the molds themselves are not directly applying a therapy to the patient. They are tools used in the creation of a temporary implant.
No
Explanation: The device is described as a temporary hemi-hip replacement used in a two-stage revision procedure due to a septic process. Its purpose is to mold and provide a temporary implant, not to diagnose a condition.
No
The device description explicitly mentions physical components like "disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts" and "biomedical grade silicone" and "implant grade stainless steel," indicating it is a hardware device, not software-only.
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, or tissue) to provide information about a person's health.
- Device Function: The described device is a mold used to create a temporary surgical implant (a cement spacer) that is placed inside the patient's body. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states it's for molding a temporary hemi-hip replacement for surgical implantation during a two-stage revision procedure.
Therefore, this device falls under the category of a surgical implant or a device used in a surgical procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The StageOne" Select hemi-hip prosthesis is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Product codes
KWY, KWL
Device Description
Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of antibiotic impregnated bone cement. The spacers are intended for short-term duration use only, not to exceed 6 months.
The StageOne" Select Cement Spacer Molds are a series of Cement Spacer Molds designed to provide modularity of sizing between the femoral stem and the femoral head connponents. The molds provide various stem sizes and various head sizes that can be mated to provide the best fit for each patient. The cement spacer molds are made of biomedical grade silicone. The metal reinforcements within the cement spacer molds are made of implant grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral medullary canal and acetabular cavity (for the temporary prosthesis)
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
Non-Clinical Testing: Cyclic fatigue testing was conducted on the StageOne" Select components and the predicate StageOne" components to provide a direct comparison of the subject and predicate components.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
K080979 P.1/2
Image /page/0/Picture/1 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in large, block letters at the top of the image. Below that, the words "ORTHOPEDICS, INC." are written in a smaller font.
OCT 3 1 2008
SECTION 5: 510(K) SUMMARY
| Preparation Date: | April 2, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corporation |
| Contact Person: | Gary Baker, MS RAC |
| Proprietary Name: | StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement. |
| Common Name: | Bone Cement Spacer Mold; Disposable Cement Spacer Molds for |
| Temporary Hip Prosthesis | |
| Classification Name: | Hip joint, femoral (hemi-hip) metallic cemented or uncemented |
| prosthesis (21 CFR § 888.3390 & 21 CFR § 888.3360). |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: StageOne" Disposable Cement Spacer Mold (K052990) - Biomet Inc. Tecres Spacer-G Temporary Hip Prosthesis (K031841) - Exactech Inc.
Device Description:
Cement Spacer Molds are designed to mold a temporary "spacer" hip implant made of antibiotic impregnated bone cement. The spacers are intended for short-term duration use only, not to exceed 6 months.
The StageOne" Select Cement Spacer Molds are a series of Cement Spacer Molds designed to provide modularity of sizing between the femoral stem and the femoral head connponents. The molds provide various stem sizes and various head sizes that can be mated to provide the best fit for each patient. The cement spacer molds are made of biomedical grade silicone. The metal reinforcements within the cement spacer molds are made of implant grade stainless steel.
Indications for Use:
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and inserted into the femoral medullary canal and
Mailing Address:
PO. Box 667
Warsaw, IN 46581-0667
Toll Free: 800 348 9500
Office 574.267 6639
Manl ar 574.267.8137
www.romel con
Silvisión Addesso
Section 5 -- Page 1
1
acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The StageOne" Select hemi-hip prosthesis is not intended for use more than 180 days, at which time it must he explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Summary of Technologies:
The StageOne" Select Cement Spacer Molds arc made of biomedical grade Silicone rubber, and are not to be implanted. The metal reinforcement stem within the femoral stem mold is made from 316 L Stainless Steel. The taper adapter and the head insert included within the head mold are made of implant grade 316 LVM Stainless Steel. The StageOne" Select cement spacer molds use Cobali G-HV Bone Cement cleared for marketing in K051532.
Non-Clinical Testing:
Cyclic fatigue testing was conducted on the StageOne" Select components and the predicate StageOne" components to provide a direct comparison of the subject and predicate components.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure. The letters "USA" are visible at the top right of the logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2008
のスタートには、アイデントがあります。 その他のお気になる。
Biomet Manufacturing Corp. % Mr. Gary Baker, MS RAC Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Rc: K080979 Trade/Device Name: Stageone™ Select Cement Spacer Molds for Temporary Hip Replacement Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY, KWL Dated: October 22, 2008 Received: October 27, 2008
Dear Mr. Baker:
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Gary Baker, MS RAC
Contraction Controller College of Caller a Cases of Conserver
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,
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 - INDICATIONS FOR USE
の新品を使用したときになると、その他、その他の場合は、その他の場合はないということです。 この日には、 この時には、 この時には、 この日には、 に、 に、 。 。
Ko809 510(k) Number (if known):
Device Name: StageOne™ Select Cement Spacer Molds for Temporary Hip Replacement.
Indications for Use:
Disposable cement spacer molds with stainless steel reinforcement stems, adaptors and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is assembled and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The StageOne" Select hemi-hip prosthesis is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.)
to the inherent mechanical limitations of the hemi-hip prosthesis Due material (polymethylmethacrylate/gentamicin), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period,
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilredsl for mxm
Division of General, Restorative, and Neurological D
510(k) Number K080979
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