(172 days)
Not Found
No
The summary describes a physical mold used to create a temporary knee prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device (molds) is used to create a temporary knee prosthesis, which is implanted in the body to address a medical condition (septic process in the knee) and restore function, thereby classifying it as a therapeutic device.
No
The device is a mold used to create a temporary knee prosthesis, which is a therapeutic device implanted in patients. It is not used to diagnose a medical condition.
No
The device description clearly states that the device is a physical mold used to create a temporary knee prosthesis from bone cement. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a mold used to create a temporary knee prosthesis. It is used during a surgical procedure and the resulting prosthesis is implanted into the patient's body.
- Intended Use: The intended use is to create a temporary implant for patients undergoing a two-stage knee replacement due to infection. This is a surgical and therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The device description and intended use clearly indicate a surgical tool and an implantable device, which fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-temporary 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.
Product codes (comma separated list FDA assigned to the subject device)
JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Surgeon, point of care
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)
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.
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.
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
§ 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
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: (574) 267-6639 Fax: (574) 372-1683
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 (800) 638-2041 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
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