(236 days)
Not Found
No
The summary describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended use of the device includes "relief of pain and significant disability," "correction of functional deformity," and treatment of conditions like "osteoarthritis and avascular necrosis" and "rheumatoid arthritis," which are all therapeutic aims.
No
This device is a shoulder implant (Comprehensive Convertible Glenoid Baseplate) used for surgical repair or replacement, not for diagnosing medical conditions. The "Intended Use" section clearly describes its application in treating various shoulder pathologies like osteoarthritis, avascular necrosis, and rotator cuff deficiency, which are indications for a therapeutic device.
No
The device description clearly details physical components of a shoulder implant, including a baseplate, screws, liners, and stems, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly indicates this device is a surgical implant for replacing or repairing the shoulder joint. It is a physical component intended to be placed within the body.
- Lack of Diagnostic Activity: There is no mention of this device analyzing biological samples or providing diagnostic information about a patient's health status. Its purpose is mechanical and structural.
Therefore, this device falls under the category of a medical device, specifically a surgical implant, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Anatomic Applications
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular. necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed Inadequate.
- Difficuit clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the Implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Comprehensive Convertible Glenoid Baseplate components are Intended for cementless applications with the addition of screw fixation.
Interiok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWT, PAO, MBF
Device Description
The Comprehensive Convertible Glenoid Baseplate is round, truncated on the anterior and posterior sides. The baseplate features a medial boss through which a Central Screw is placed to hold the component in place. The back surface of the component is porous coated. There are two peripheral screw holes through the baseplate. Screws are available in both locking and non-locking styles. When used with a polyethylene liner, the construct is designed to articulate with a metallic humeral head attached to a humeral stem in a traditional, anatomic total shoulder configuration. Should revision to a reverse shoulder construct be desirable, the polyethylene liner can be removed without removal of the baseplate and replaced with a glenosphere component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 Tests Conducted For Determination Of Substantial Equivalence:
Range of motion, Axial separation of tapers, Torsional separation of tapers, Axial pull-off of bearings, Shear separation of bearings, FEA Stress Simulation, Initial fixation, Disassociation, Shear Load to Failure.
Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information:
No clinical data submitted.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA:
No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
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.
SMRTM Modular Glenoids (K113254), BioModular® Shoulder System (K992119, K030710), Comprehensive® Reverse Shoulder (K080642, K120121)
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
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing 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 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Biomet Manufacturing Corporation Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K130390
Trade/Device Name: Comprehensive Convertible Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, PAO, MBF Dated: August 21, 2013 Received: August 22, 2013
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of October 9, 2013.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
Page 2 - Ms. Patricia Sandborn Beres
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K130390
Device Name: Comprehensive Convertible Glenoid
Indications For Use:
Anatomic Applications
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular. 1. necrosis.
- Rheumatoid arthritis. 2.
- Revision where other devices or treatments have failed. 3.
- Correction of functional deformity. 4.
- Fractures of the proximal humerus, where other methods of treatment are deemed 5. Inadequate.
- Difficuit clinical management problems, including cuff arthropathy, where other methods of 6. treatment may not be suitable or may be inadequate.
Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the Implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Comprehensive Convertible Glenoid Baseplate components are Intended for cementless applications with the addition of screw fixation.
Interiok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Prescription Use × (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)
Image /page/2/Picture/21 description: The image shows a logo with the text "Casey C. Hanley, Ph.D." on the top line. Below a horizontal line, the text "Division of Orthopedic Devices" is displayed. The logo appears to be for a division related to orthopedic devices, possibly within a company or organization associated with Casey C. Hanley.
Page 1 of 1
3
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| SUBMITTER INFORMATION | ||
|---|---|---|
| Name | Biomet Manufacturing Corp. | |
| Address | 56 East Bell Drive | |
| Warsaw, IN 46582 | ||
| Phone number | (574) 267-6639 | |
| Fax number | (574) 371-1027 | |
| Establishment Registration Number | 1825034 | |
| Name of contact person | Patricia Sandborn Beres | |
| Senior Regulatory Specialist | ||
| Biomet Manufacturing Corp. | ||
| Date prepared | August 16, 2013 | |
| NAME OF DEVICE | ||
| Trade name | Comprehensive® Convertible Glenoid | |
| Common name | Glenoid prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint, metal/polymer, semi- | ||
| constrained, cemented prosthesis | 21 CFR 888.3660 | KWS |
| Shoulder joint metal/polymer non-constrained | ||
| cemented prosthesis | 21 CFR 888.3650 | KWT |
| Shoulder joint metal/polymer (+additive) semi- | ||
| constrained cemented prosthesis | 21 CFR 888.3660 | PAO |
| Shoulder joint metal/polymer/metal | ||
| nonconstrained or semi-constrained porous- | ||
| coated uncemented prosthesis | 21 CFR 888.3670 | MBF |
| Classification panel | Orthopedics | |
| Legally marketed device(s) to which | ||
| equivalence is claimed | SMRTM Modular Glenoids (K113254) | |
| BioModular® Shoulder System (K992119, K030710) | ||
| Comprehensive® Reverse Shoulder (K080642, K120121) | ||
| Reason for 510(k) submission | New device | |
| Device description | The Comprehensive Convertible Glenoid Baseplate is | |
| round, truncated on the anterior and posterior sides. | ||
| The baseplate features a medial boss through which a | ||
| Central Screw is placed to hold the component in | ||
| place. The back surface of the component is porous | ||
| coated. There are two peripheral screw holes through | ||
| the baseplate. Screws are available in both locking | ||
| and non-locking styles. When used with a | ||
| polyethylene liner, the construct is designed to | ||
| articulate with a metallic humeral head attached to a | ||
| humeral stem in a traditional, anatomic total shoulder | ||
| configuration. Should revision to a reverse shoulder | ||
| construct be desirable, the polyethylene liner can be | ||
| removed without removal of the baseplate and | ||
| replaced with a glenosphere component. |
.
Mailing Address:
Radion Milliano Million Microsof
Transform (10) Market Market Start (10000)
Official Endry (1000) Start (1000) Official (1000)
William Country (100%)
Shipping Address:
56 East Bcc Drive
Wersew, IN 46502
4
510(k) Summary
Comprehensive® Convertible Glenoid
Page 2 of 3
| Indications
| for use | Anatomic Applications | |||
|---|---|---|---|---|
| 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular | ||||
| necrosis. |
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus, where other methods of treatment are deemed
inadequate. - Difficult clinical management problems, including cuff arthropathy, where other
methods of treatment may not be suitable or may be inadequate.
Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint
has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder
joint replacement with a grossly deficient rotator cuff. The patient must be anatomically
and structurally suited to receive the implants and a functional deltoid muscle is
necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total
shoulder replacement for the relief of pain and significant disability due to gross rotator
cuff deficiency.
Comprehensive Convertible Glenoid Baseplate components are intended for cementless
applications with the addition of screw fixation.
Interlok finish humeral stems are intended for cemented use and the MacroBond coated
humeral stems are intended for press-fit or cemented application. Humeral components
with porous coated surface coating are indicated for either cemented or uncemented | | | |
| | SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE | | | |
| | Comprehensive®
Convertible
Glenoid | SMR™ Modular
Glenoid | Bio-Modular®
Glenoid | Comprehensive®
Reverse Shoulder |
| Material | Ti-6Al-4V
UHMWPE | Ti-6Al-4V
UHMWPE | Ti-6Al-4V
UHMWPE | Ti-6Al-4V |
| Profiles | Truncated round | Truncated round | Pear shaped | Round |
| Sizes | 23 x 28mm | Small-R, Small,
Standard, Large | Small, Medium,
Large | 25 and 28mm |
| Poly/Tray
Attachment | Four pegs | Snap-fit
Central lug | One peg | NA |
| Glenosphere
Attachment | Taper Adapter | Taper Post | NA | Taper Adapter |
| Surface
Coatings | Porous plasma spray | Porous plasma
spray | Porous plasma spray | Porous plasma spray
with HA |
| Features | Central screw boss
Two screw holes | Central Post
Two screw holes | Central post
Two screw holes | Medial Boss w/Screw
Four screw holes |
・
'
5
510(k) Summary
Comprehensive® Convertible Glenoid
Page 3 of 3
.
.
| PERFORMANCE DATA | |
|---|---|
| Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Range of motion | Axial separation of tapers |
| Torsional separation of tapers | Axial pull-off of bearings |
| Shear separation of bearings | FEA Stress Simulation |
| Initial fixation | Disassociation |
| Shear Load to Failure | |
| Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical Information | |
| No clinical data submitted | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| No clinical data was necessary for a determination of substantial equivalence. The results of testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices. |
・