(242 days)
Not Found
No
The device description focuses on the mechanical components and materials of a physical implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The customization is based on patient anatomy measurements, not AI/ML analysis.
Yes
The device is an implantable prosthesis used to replace the humeral-ulnar articulation of the human elbow, addressing various medical conditions like arthritis, avascular necrosis, and fractures, which clearly indicates its therapeutic purpose.
No
The device is described as an implant used to replace a joint, which indicates a therapeutic rather than a diagnostic purpose. While it specifies the use of imaging for custom design, this is for manufacturing/sizing an implant, not for diagnosing a condition.
No
The device description clearly details physical components made of titanium alloy, cobalt chromium, and polyethylene, which are surgically implanted. This is a hardware medical device, not software-only.
Based on the provided text, 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 Description: The description clearly states that this device is a "constrained, 'sloppy-hinge' elbow device used to replace the humeral-ulnar articulation of the human elbow." It is an implantable prosthesis.
- Intended Use: The intended use describes the conditions for which the device is used within the body (rheumatoid arthritis, fractures, etc.) and its function as a replacement joint.
There is no mention of this device being used to test samples outside of the body. It is a surgical implant.
N/A
Intended Use / Indications for Use
The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.
This device is a single use implant. It is intended for use with bone cement.
Product codes
JDC
Device Description
The Single Axle Total Elbow Prosthesis is a constrained, "sloppyhinge" elbow device used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar component and a humeral component, which are joined by an axle (refer to Exhibit III). The Single Axle Elbow features a "sloppy-hinge" that will allow for 16 degrees of varus/valgus movement (refer to Exhibit III). A hyperextension stop (flat) is placed on the ulnar component to control the amount of hyperextension allowed by the device. The device shown in Exhibit III was designed to have 0 degrees of hyperextension, but some hyperextension may be allowed at the specific request of the surgeon. The amount of flexion of the device is approximately 137 degrees (see Exhibit III), but this may also change somewhat due to specific patients' anatomy and surgeon requests.
The humeral component will be made of titanium alloy. Each humeral component will be custom designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the humeral component may include a replacement portion if distal humeral bone loss exists (refer to Exhibit IV). A portion of the extramedullary and intramedullary sections of the humeral component may be plasma sprayed with the remainder of the intramedullary portion having a bead blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions.
The ulnar component will be made of titanium alloy. The ulnar and humeral components will be separated by a polyethylene Saddle Bearing to prevent metal on metal contact (refer to Exhibit III). Each ulnar component will be designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the ulnar component may include a replacement portion if proximal ulnar bone loss exists (refer to Exhibit IV). The ulnar component may also contain through slots posteriorly for the attachment of soft tissues. A portion of the extramedullary and intramedullary sections of the ulnar component may be plasma sprayed to 0.030/0.040" thick or a thinner coating (Bondcoat), with the remainder of the intramedullary portion having a bead-blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions.
The humeral and ulnar components are connected by an axle bearing, metal reinforcing rod or axle and a saddle bearing. The metal reinforcing rod or axle is cobalt chromium. The axle is sleeved by an axle bearing, which is manufactured from ultra high molecular weight polyethylene (UHMWPE). The axle retaining clips are manufactured from titanium alloy. The saddle bearing is also manufactured from UHMWPE. The saddle bearing. axle bearing, and retaining clips will be consistent for all Biomet Single Hinge Elbows.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays, CT-scans, or some other media for measuring patient anatomy.
Anatomical Site
Elbow
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
4/30/99
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet, Inc.
Airport Industrial Park
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|---------------------------------------------------------------------------------------|
| Device: | Single Axle Total Elbow |
| Classification Name: | Elbow joint metal/polymer constrained cemented
prosthesis(888.3150) |
Intended Use: The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.
This device is a single use implant. It is intended for use with bone cement.
Device Description: The Single Axle Total Elbow Prosthesis is a constrained, "sloppyhinge" elbow device used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar component and a humeral component, which are joined by an axle (refer to Exhibit III). The Single Axle Elbow features a "sloppy-hinge" that will allow for 16 degrees of varus/valgus movement (refer to Exhibit III). A hyperextension stop (flat) is placed on the ulnar component to control the amount of hyperextension allowed by the device. The device shown in Exhibit III was designed to have 0 degrees of hyperextension, but some hyperextension may be allowed at the specific request of the surgeon. The amount of flexion of the device is approximately 137° (see Exhibit III), but this may also change somewhat due to specific patients' anatomy and surgeon requests.
The humeral component will be made of titanium alloy. Each humeral component will be custom designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the humeral component may include a replacement portion if distal humeral bone loss exists (refer to Exhibit IV). A portion of the extramedullary and intramedullary sections of the humeral component may be plasma sprayed with the remainder of the intramedullary portion having a bead blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions.
The ulnar component will be made of titanium alloy. The ulnar and humeral components will be separated by a polyethylene Saddle Bearing to prevent metal on metal contact
00043
1
(refer to Exhibit III). Each ulnar component will be designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the ulnar component may include a replacement portion if proximal ulnar bone loss exists (refer to Exhibit IV). The ulnar component may also contain through slots posteriorly for the attachment of soft tissues. A portion of the extramedullary and intramedullary sections of the ulnar component may be plasma sprayed to 0.030/0.040" thick or a thinner coating (Bondcoat), with the remainder of the intramedullary portion having a bead-blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions
The humeral and ulnar components are connected by an axle bearing, metal reinforcing rod or axle and a saddle bearing. The metal reinforcing rod or axle is cobalt chromium. The axle is sleeved by an axle bearing, which is manufactured from ultra high molecular weight polyethylene (UHMWPE). The axle retaining clips are manufactured from titanium alloy. The saddle bearing is also manufactured from UHMWPE. The saddle bearing. axle bearing, and retaining clips will be consistent for all Biomet Single Hinge Elbows.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
- Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Dislocation
- Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Breakdown of porous surface
Substantial Equivalence: In function and overall design Biomet's Single Axle Total Elbow is equivalent to almost all elbow joint metal/polymer cemented constrained prostheses on the market. Predicate devices include:
Townley Total Elbow (Biopro, 1996, 510(k) #K955916) Osteonics Total Elbow System (Osteonics 1998, 510(k) #980502) ABC Total Elbow Prosthesis (Biomet, Inc., 1997, 510(k) #972691)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 300 1999
Mr. Fred McClure Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana
K983036 Re: Sinqle Axle Total Elbow Trade Name: Regulatory Class: III Product Code: JDC Dated: February 19, 1999 February 22, 1999 Received:
Dear Mr. McClure:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Fred McClure
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known) : K983036
Device Name: Single Axle Total Elbow
The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-Indications For Use: inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.
This device is a single use implant. It is intended for use with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
Division Sign-Off)
(Divis Division of General Res 510(k) Number