(76 days)
The Comprehensive® Primary Shoulder Stems are intended for hemi or total shoulder replacement:
- 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 tear arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenold components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenold components offer optional screw fixation.)
The Comprehensive® Primary Shoulder Stems are intended for use only with the Blo-Modular@ humeral heads and glenoid components and the Versa-Dial™ humeral head components.
The devices are single-use implants.
The Comprehensive® Primary Shoulder Stems are humeral stems comprised of titanium alloy. The stems are available in various lengths and sizes. Portions of the devices are coated with plasma-spray titanium porous coating. The taper geometry of the new devices is the exactly the same as the predicate Comprehensive® Humeral Fracture Stems (K023063). The new devices are comprised of the exact same material as the predicate Bio-Modular® Shoulder System stems (K030710). The Comprehensive® Primary Shoulder Stems are designed to be used with Biomet's Bio-Modular® and Versa-Dial™ humeral heads and can be used in hemi or total shoulder arthroplasty.
This document describes the Biomet Manufacturing Corp.'s "Comprehensive Primary Shoulder Stems" device, which received 510(k) clearance (K060692) from the FDA on May 30, 2006.
The 510(k) summary explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means that the device's substantial equivalence to predicate devices was not established through clinical trials comparing its performance against predefined acceptance criteria. Instead, it was based on non-clinical testing and similarity to predicate devices.
Therefore, the following information, which typically pertains to clinical studies and acceptance criteria, cannot be provided from the given document:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
What can be extracted from the document regarding the study:
Summary of Study (Non-Clinical):
- Type of Study: Non-clinical laboratory testing.
- Purpose: To determine substantial equivalence to predicate devices.
- Findings: "The results indicated that the device was functional within its intended use."
Details Available from the Document:
- Device Name: Comprehensive® Primary Shoulder Stems
- Applicant/Sponsor: Biomet Manufacturing Corp.
- FDA 510(k) Number: K060692
- Approval Date: May 30, 2006
- Predicate Devices:
- Technological Characteristics Comparison: The technological characteristics (material, design, sizing, indications) of the Comprehensive® Primary Shoulder Stems are similar or identical to the predicate devices. Specifically:
Conclusion:
The 510(k) clearance for the Comprehensive® Primary Shoulder Stems was based on non-clinical bench testing demonstrating functionality and substantial equivalence to existing predicate devices, rather than a clinical study with predefined acceptance criteria for performance metrics on patient data. Therefore, the detailed information requested about acceptance criteria, clinical study parameters, and AI-related performance metrics is not applicable or available in the provided document.
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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, bold font. Above the word "BIOMET" is the date "MAY 30 2006". The text is black and the background is white. The word "BIOMET" is in all caps.
b0692
510(k) Summary
| Preparation Date: | March 13, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Comprehensive® Primary Shoulder Stems |
| Common Name: | Shoulder Prosthesis |
Classification Name:
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer, Cemented (21 CFR §888.3650) .
- . Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented (21 CFR §888.3660)
- Shoulder Joint, Metal/Polymer/Metal, Non-Constrained or Semi-Constrained, Porous Coated, . Uncemented Prosthesis (21 CFR §888.3670)
- . Shoulder Joint, Humeral, (Hemi-Shoulder), Metallic, Uncemented Prosthesis (21 CFR §888.3690)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
- Bio-Modular® Shoulder System; Biomet Manufacturing; Corp. (K030710) .
- Comprehensive® Humeral Fracture Stems; Biomet Manufacturing Corp. (K023063) .
- . Integrated™ Shoulder System (Kirschner Shoulders with Titanium Plasma Spray); Biomet, Inc. (K961260)
Device Description:
The Comprehensive® Primary Shoulder Stems are humeral stems comprised of titanium alloy. The stems are available in various lengths and sizes. Portions of the devices are coated with plasma-spray titanium porous coating. The taper geometry of the new devices is the exactly the same as the predicate Comprehensive® Humeral Fracture Stems (K023063). The new devices are comprised of the exact same material as the predicate Bio-Modular® Shoulder System stems (K030710). The Comprehensive® Primary Shoulder Stems are designed to be used with Biomet's Bio-Modular® and Versa-Dial™ humeral heads and can be used in hemi or total shoulder arthroplasty.
Intended Use: The Comprehensive® Primary Shoulder Stems are indicated for:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis. 1)
-
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed. 3)
-
- Correction of functional deformity.
-
- Fractures of the proximal humerus where other methods of treatment are deemed inadequate.
-
- Difficult clinical management problems, including cuff tear arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation.)
5 - 1
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FAX -574.267.8137
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K060692 p²/₂
The Comprehensive® Primary Shoulder Stems are intended for use only with the Bio-Modular® humeral heads and glenoid components and the Versa-Dial™ humeral head components.
The devices are single-use implants.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the Comprehensive® Primary Shoulder Stems are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Unless otherwise indicated, all trademarks are property of Biomet.
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510 (K)・ROUTE SLIP TRADITIONAL
| 510 (k) NUMBER | K060692 | PANEL OR | DIVISION DGRND | BRANCH |
|---|---|---|---|---|
| ELECTRONIC SUBMISSION | N | |||
| TRADE NAME | COMPREHENSIVE PRIMARY SHOULDER STEMS | |||
| COMMON NAME | SHOULDER PROSTHESIS | |||
| PRODUCT CODE | ||||
| APPLICANT | BIOMET MANUFACTURING CORP. | |||
| SHORT NAME | BIOMETE | |||
| CONTACT | SUSAN ALEXANDER | |||
| DIVISION | ||||
| ADDRESS | PO BOX 58756. E. BELL DRIVEWARSAW, IN 465810587 | |||
| PHONE NO. | (574) 267-6639 | FAX NO. | (574) 372-1683 | |
| MANUFACTURER | BIOMET MANUFACTURING CORP.STERIS ISOMEDIX SERVICES | REG NO. | 14506621450662 | |
| DATE ON SUBMISSION | 13-MAR-2006 | DATE DUE POS | 29-APR-2006 | |
| DATE RECEIVED IN ODE | 15-MAR-2006 | 75th DAY | 29-MAY-2006 | |
| DECISION | DECISION DATE | |||
| Is this 510(k) identified as a Class III device | YESYES | NO | ||
| Is this 510(k) the result of additional information | YESYES | NO |
CD Enclosed
Ream SE
gss 5/24/06
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 30 2006
Biomet Manufacturing Corp. c/o Ms. Susan Alexander Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K060692
Trade/Device Name: Comprehensive Primary Shoulder Stems Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal non-constrained or semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD Dated: March 13, 2006 Received: March 15, 2006
Dear Ms. Alexander:
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, 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 (PMA), 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 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); good manufacturing practice requirements as set
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Page 2 - Ms. Susan Alexander
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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Akut Lemmer wo
← Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Comprehensive® Primary Shoulder Stems
Indications For Use:
The Comprehensive® Primary Shoulder Stems are intended for heml or total shoulder replacement:
-
- 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 tear arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenold components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenold components offer optional screw fixation.)
The Comprehensive® Primary Shoulder Stems are intended for use only with the Blo-Modular@ humeral heads and glenoid components and the Versa-Dial™ humeral head components.
The devices are single-use implants.
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)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
| K060692 |
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”