(10 days)
No
The 510(k) summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The Biomet® Bi-Polar Shoulder System is indicated for treating various medical conditions such as degenerative joint disease, rheumatoid arthritis, fractures, and for revision surgeries, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a Bi-Polar Shoulder System, which is an implant used for joint replacement, not for diagnosing conditions.
No
The device description clearly describes a physical implantable medical device (humeral shell, liner, locking ring) and its components, not a software-only product.
No, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text describes a surgical implant for replacing parts of the shoulder joint. It is a physical device intended to be surgically placed within the body to restore function and alleviate pain.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its purpose is purely therapeutic and reconstructive.
Therefore, based on the provided information, the Biomet® Bi-Polar Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biomet® Bi-Polar Shoulder System is indicated for use in:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
-
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods
-
- Cuff tear arthroplasty
Product codes
87 KWT, 87 MBF
Device Description
The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be . used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis.
- In assembling, the liner is place over a modular inner head that is already impacted to . an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis.
- The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 . mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, humeral head
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 (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
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and 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,” and
(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,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(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 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
SUMMARY OF SAFETY AND EFFECTIVENESS
Sponsor:
Biomet Inc. Airport Industrial Park P.O. Box 587 Warsaw. IN 46581-0587
| Contact Person: | Tracy J. Bickel |
|---|---|
| (219) 372-1761 |
Biomet® Bi-Polar Shoulder System Device(s):
Prosthesis, shoulder, non-constrained, metal/polymer, cemented Classification:
Device Product Code: 87 KWT (21 CFR 888.3650) 87 MBF (Unknown, recently down classified)
Intended Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
-
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods
-
- Cuff tear arthroplasty
Device Description:
- The Biomet® Bi-Polar Shoulder Prosthesis is a self-retaining humeral shell that can be . used with either the Bi-Angular® humeral prosthesis or the Bio-Modular® humeral prosthesis.
- In assembling, the liner is place over a modular inner head that is already impacted to . an implanted humeral stem. The shell is then placed over the liner and the Ring-Loc lock ring snaps into the outer groove of the liner, which completes assembly of the prosthesis.
- The shell is available in six spherical diameters, 40 mm, 48 mm, 52 mm, 56 . mm and 60 mm. The liner and Ring-Loc® locking ring are modular, i.e. there is only one size of each, and each is used with all six shell sizes.
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 Deformity of the joint Cardiovascular disease
Blood vessel damage Soft tissue imbalance Delayed wound healing
Bone fracture · Infection Hematoma
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1
Fracture of the cement Implant loosening/migration Tissue growth failure
Metal sensitivity Fracture of the components Nerve damage
Dislocation Excessive wear
Predicate Device(s):
Biomet® Bi-Polar Shoulder, K991585
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 eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT = 6 2000
Ms. Tracy J. Bickel Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K002998
Trade Name: Biomet® Bi-Polar Shoulder Regulatory Class: II Product Code: KWT and MBF Dated: September 18, 2000 Received: September 26, 2000
Dear Ms. Bickel:
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 control provisions of the Act. The general control 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 (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. A 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 action. In addition, FDA may publish further announcements 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.
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.
3
Page 2 - Ms. Tracy J. Bickel
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 vours,
Mark N Melkerson
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
4
Page of
K002998 510(k) Number (if known): _ Device Name: Biomet® Bi-Polar Shoulder System Indications for Use:
The Biomet® Bi-Polar Shoulder System is indicated for use in:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Revision where other devices or treatments have failed
-
- Correction of functional deformity
-
- Treatment of acute fracture of the humeral head unmanageable using other treatment methods
-
- Cuff tear arthroplasty
This is a single use implant for use with cemented or uncemented humeral components. It is intended for use with Biomet's humeral components previously cleared by the FDA.
Mark n Millerson
vision Sien-Off Division of General Restorative Devices 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
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