(30 days)
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.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application 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 applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
The Comprehensive® Reverse Shoulder is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional total shoulder replacement, a reverse shoulder employs a ball for articulation on the glenoid side of the joint and a polyethylene bearing surface on the humeral side of the joint. This device configuration increases the lever arm of the deltoid muscle bundle to provide stability and the ability to raise the arm. This is especially useful in cases where a patient has a non-functioning rotator cuff which severely limits traditional joint replacement options.
This document describes a 510(k) premarket notification for the "Comprehensive® Reverse Shoulder - Mini Baseplate" device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Comprehensive® Reverse Shoulder, 510(k) K080642), rather than establishing new acceptance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML or diagnostic device is not directly applicable here.
However, I can extract the relevant information regarding the performance data section and how substantial equivalence was demonstrated for this medical device, which serves a similar purpose of proving the device's safety and effectiveness compared to an existing standard.
Here's a breakdown of the available information structured to best fit your request:
1. Table of Acceptance Criteria and Reported Device Performance
In the context of this 510(k) submission for a medical implant, "acceptance criteria" refers to demonstrating that the new device (Mini Baseplate) performs equivalently to the predicate device in terms of mechanical properties and materials, ensuring it is safe and effective for its intended use. The table below summarizes the comparison to the predicate device. Specific numerical acceptance criteria are not explicitly stated as pass/fail thresholds in this summary but are implied by the statement "performed within the intended use" and "did not raise any new safety and efficacy issues."
| Characteristic | Predicate Device (Comprehensive® Reverse Shoulder - 510(k) K080642) | Modified Device (Comprehensive® Reverse Shoulder - Mini Baseplate) | Basis for Acceptance (Implied) |
|---|---|---|---|
| Form/Fit | |||
| Sizes (Glenosphere Baseplate) | 28mm | 25mm | The modified device introduces a smaller size (25mm) compared to the predicate device (28mm). Mechanical testing was performed to demonstrate the safety and effectiveness of this new size. |
| Profile (Glenosphere Baseplate) | Round | Round | Geometrically equivalent. |
| Material/Construction | |||
| Surface Finish | Plasma Spray/HA | Plasma Spray/HA | Identical. |
| Material | Ti-6Al-4V | Ti-6Al-4V | Identical. |
| Central Fixation | Medial boss with 6.5mm Screw | Medial boss with 6.5mm Screw | Identical. |
| Taper Adapter for Glenosphere | Standard | Mini | The modified device uses a "Mini" taper adapter, implying a design change that likely necessitated specific mechanical testing. |
| Performance Data | Substantial Equivalence to Predicate Device (K080642) | ||
| Compressed Shear Load to Failure Testing | Not explicitly detailed but implied baseline for comparison | Performed | Results indicated performance within the intended use and no new safety/efficacy issues. |
| Baseplate Fixation Testing | Not explicitly detailed but implied baseline for comparison | Performed | Results indicated performance within the intended use and no new safety/efficacy issues. |
| Axial Separation Testing | Not explicitly detailed but implied baseline for comparison | Performed | Results indicated performance within the intended use and no new safety/efficacy issues. |
| Torsional Separation Testing | Not explicitly detailed but implied baseline for comparison | Performed | Results indicated performance within the intended use and no new safety/efficacy issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For mechanical testing of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., n=5 or n=6 per group for certain tests), but the exact numbers are not provided in this summary.
- Data Provenance: The tests are non-clinical (mechanical bench testing). Therefore, there is no "country of origin of the data" in the human data sense, nor is it retrospective or prospective. The data is generated in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of submission. "Ground truth" in this context would refer to the physical and mechanical properties of the materials and device components. The "truth" is established by standard engineering principles and validated testing methods according to recognized standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert judgment in clinical or diagnostic studies. This submission relies on objective mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and AI assistance can potentially improve their performance. This submission is for a surgical implant, not a diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No, a standalone algorithm performance study was not done. This point is relevant for AI/ML diagnostic tools.
7. Type of Ground Truth Used
The "ground truth" for non-clinical performance data for an orthopedic implant like this is based on:
- Material specifications: Compliance of the Ti-6Al-4V material to established standards (e.g., ASTM F136).
- Design specifications: The dimensions and geometric features of the components.
- Mechanical properties: The measured strength, stiffness, fixation integrity, and separation resistance against established performance benchmarks or comparisons to the predicate device, as determined by standardized mechanical testing methods.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product and does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth established in this manner.
In summary: The submission demonstrates substantial equivalence of the "Comprehensive® Reverse Shoulder - Mini Baseplate" to its predicate device through non-clinical performance testing (e.g., compressed shear load, baseplate fixation, axial separation, torsional separation). The results of these tests confirmed that the modified device "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." This is the primary "proof" for regulatory acceptance for this type of medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Biomet, Incorporated Ms. Patricia Beres Senior Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K120121
Trade/Device Name: Comprehensive® Reverse Shoulder - Mini-Baseplate Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX. KWS Dated: January 13, 2012 Received: January 17, 2012
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of February 16, 2012.
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
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/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
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Indications for Use
510(k) Number (if known):_ |< | 2 012 |
Device Name: Comprehensive® Reverse Shoulder - Mini Baseplate
Indications For Use:
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.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation,
Interiok finish humeral stems are intended for cemented use and the MacroBond® coated with parave and the hotel for press-fit or cemented applications. 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 AND/OR AND/OR AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD AND/ORD A
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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K120121
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K12012) ('/2)
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FEB 1 6 2012
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 DriveWarsaw, IN 46582 | |
| Phone number | (574) 267-6639 | |
| Fax number | (574) 371-1027 | |
| Establishment RegistrationNumber | 1825034 | |
| Name of contact person | Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp. | |
| Date prepared | January 4, 2011 | |
| NAME OF DEVICE | ||
| Trade or proprietary name | Comprehensive® Reverse Shoulder - Mini Baseplate | |
| Common or usual name | Shoulder Prosthesis | |
| Classification name | Shoulder joint, metal/polymer, semi-constrained, cementedprosthesis | |
| Classification panel | Orthopedics | |
| Regulation | 21 CFR 888.3660 | |
| Product Code(s) | KWS | |
| Legally marketed device(s) to which equivalence isclaimed | Comprehensive® Reverse Shoulder510(k) K080642 | |
| Reason for 510(k)submission | Line Extension | |
| Device description | The Comprehensive® Reverse Shoulder is intended for totalshoulder replacement in a reverse shoulder configuration. Unliketraditional total shoulder replacement, a reverse shoulderemploys a ball for articulation on the glenoid side of the joint anda polyethylene bearing surface on the humeral side of the joint.This device configuration increases the lever arm of the deltoidmuscle bundle to provide stability and the ability to raise thearm. This is especially useful in cases where a patient has anon-functioning rotator cuff which severely limits traditional jointreplacement options. | |
| Intended use of the device | Shoulder Replacement | |
| Indications for use | The Comprehensive® Reverse Shoulder is indicated for use inpatients whose shoulder joint has a grossly deficient rotator cuffwith severe arthropathy and/or previously failed shoulder jointreplacement with a grossly deficient rotator cuff. The patient mustbe anatomically and structurally suited to receive the implantsand a functional deltoid muscle is necessary.The Comprehensive® Reverse Shoulder is indicated for primary,fracture, or revision total shoulder replacement for the relief ofpain and significant disability due to gross rotator cuff deficiency.Glenoid components with Hydroxyapatite (HA) coating applied overthe porous coating are indicated only for uncemented biologicalfixation applications. The Glenoid Baseplate components areintended for cementless application with the addition of screwfixation.Interlok® finish humeral stems are intended for cemented use andthe MacroBond® coated humeral stems are intended for press-fit orcemented applications. Humeral components with porous coatedsurface coating are indicated for either cemented or uncemented | |
| biological fixation applications. | ||
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE GLENOSPHEREBASEPLATE COMPARED TO THE PREDICATE | ||
| Characteristic | Modified Device | Comprehensive® ReverseShoulder - 510(k) K080642 |
| Sizes | 25mm | 28mm |
| Profile | Round | Round |
| Surface Finish | Plasma Spray/HA | Plasma Spray/HA |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Central Fixation | Medial boss with 6.5mm Screw | Medial boss with 6.5mm Screw |
| Taper Adapter for Glenosphere | Mini | Standard |
| PERFORMANCE DATA | ||
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | ||
| Performance Test Summary-New Device | ||
| Compressed Shear Load to Failure Testing | ||
| Baseplate Fixation Testing | ||
| Axial Separation Testing | ||
| Torsional Separation Testing | ||
| Summary of clinical tests conducted for determination of substantial equivalence and/orof clinical information | ||
| No clinical data submitted | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
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Comprehensive® Reverse Shoulder - Mini Baseplate 510(k) Summary continued
The results of testing indicated the material 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.
§ 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.”