(47 days)
Not Found
No
The summary describes a mechanical elbow prosthesis and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device, a total elbow prosthesis, is intended to treat medical conditions like degenerative joint disease and rheumatoid arthritis, and to correct functional deformities or fractures. These uses align with the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.
No
Explanation: The device is an elbow prosthesis, which is a therapeutic device used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a total elbow prosthesis comprised of physical components (humeral and ulnar components) which are porous coated. This indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Porous Coated Discovery™ Elbow is a total elbow prosthesis. It is an implantable device used to replace a damaged elbow joint.
- Intended Use: The intended use describes the conditions for which the prosthesis is used in patients, all of which involve replacing or correcting issues within the elbow joint itself.
This device is a surgical implant, not a diagnostic tool that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The Porous Coated Discovery™ Elbow is intended for cemented use in patients with the following conditions:
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of severe functional deformity.
- Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.
Product codes
JDC
Device Description
The Porous Coated Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar component, a humeral component, and a humeral articulation. The humeral and ulnar components are porous coated to provide enhanced fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Mechanical testing was provided to demonstrate that devices ability to perform.
Clinical Testing: None provided as a basis of substantial equivalence.
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
§ 888.3150 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
SEP - 6 2005
Kos1975
Image /page/0/Picture/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and outlined in black. The word appears to be a logo or brand name.
510(k) Summary
Applicant/Sponsor: Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Porous Coated Discovery™ Elbow
Common Name: Constrained Elbow Joint
Classification Name: Elbow joint/polymer constrained cemented prosthesis (21 CFR 888.3150)
Legally Marketed Device To Which Substantial Equivalence Is Claimed: Biomet Discovery™ Elbow (K013042)
Device Description: The Porous Coated Discovery™ Elbow is a total elbow prosthesis Device Desonption: The Porocol component. Placing the humeral articulation comprised of an unfidrar components of components. The humeral components. The humeral through the unfar anticulation into the une and ulnar components are porous coated to provide enhanced fixation.
Intended Use: The Porous Coated Discovery™ Elbow is intended for cemented use in patients with the following conditions:
- patients with the following conditions:
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of severe functional deformity.
-
- Concection of Sciere functional doferming.
- Treatment of acute or chronic fractures with humeral epicondyle involvement, which is are unmanageable using other treatments.
Summary of Technologies: The technological characteristics (materials, design, sizing Summal y of Technologics: The toonnological entiled in are similar to or identical to the predicate devices.
Non-Clinical Testing: Mechanical testing was provided to demonstrate that devices ability to perform.
Clinical Testing: None provided as a basis of substantial equivalence.
All trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
E
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
574.267.6639
FAX 574.267.8137
E-MAIL biomet@biomet.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
SEP - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P. O. Box 587 Warsaw, Indiana 46581-0578
Re: K051975
K051973
Trade/Device Name: Porous Coated Discovery™ Elbow Praders on Number: 21 CFR 888.3150 Regulation Number: 21 CFR 868.5136
Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: August 17, 2005 Received: August 19, 2005
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > I0(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is subserverketed in intersta referenced above and have delemined the devices marketed in interstate
for use stated in the enclosure) to legally marketed president Device Amendments for use stated in the enclosure) to regary manced promoted in orice Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food Drug commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been recrassified in accordance was are approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessed approvisions of the Act . T and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general construction of listin You may, therefore, market the ucvice, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the recentered to quarterolibitions 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) mio ennier enably in the minent of the same of the same of the addition. FDA may may be subject to such additional controls. Existing in harts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Locister be found in the Code of Poderal Regaring 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 s issualice or a subscription with other requirements of the Act
that FDA has made a determination that your device aronaise. You must that FDA has made a decemination that your are ros reserve agencies. You must and list or any Federal statutes and regulations administered of registration and listing (21 l
eomply with all the Act's requirements, including, but not limited to: requirements as comply with all the Act S requirements, moradial wantics requirements as set CH Part 807); labeling (21 CFR Part 800); good and 11 applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act), 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act), 21 CFR 1000
2
This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the same of a the same of the same of your device to a legal This letter will allow you to begin marketing your article quivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA initime of substantial by 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
rs the latest of the many of 10, 2019 - All any desse mate the regulation e If you desire specific advice for your ac not on one of the regulation entitled, the regulation entitled, contact the Office of Comphalled at (217) 276 - 8 at 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain "Misbranding by reference to premarket inclifetes under the Act from the Division of Small other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance and Consumer (index) html Manufacturers, International and Consumer Abolokation on on corner in the manufactures of the
Sincerely yours,
signature
r Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Porous Coated Discovery™ Elbow
Indications For Use: The Porous Coated Discovery™ Elbow is intended for cemented mdications + or with the following conditions:
- use in patients with the following conditions.
- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- Correction of severe functional deformity.
-
- Correction of severe inncilonal delomity.
- Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatments.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (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) | |
|---|---|
| (Division Sign-Off) | Page 1 of |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K081975 |