(151 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.
Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
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 Macro Bond® 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 device is a single-use implant.
The Titanium Alloy Glenosphere Prosthesis consists of a series of various sized modular glenospheres with variable offset between 0.5mm and 4.5 mm. Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies. Each modular glenosphere consists of a "head" and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Reverse Shoulder System or Biomet's BioModular® Reverse Shoulder System.
This document is a 510(k) premarket notification for a medical device, specifically the Comprehensive® Reverse Shoulder - Titanium Glenosphere. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving that the device meets specific acceptance criteria based on performance data.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and performance metrics (like sample size for test sets, expert ground truth, effect size, etc.) are not applicable or not provided in this type of regulatory submission. The document explicitly states "No clinical data submitted" and "No clinical data was necessary for a determination of substantial equivalence."
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly defined by the characteristics and performance of the predicate devices. The performance reported here is primarily related to non-clinical bench testing.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Functional equivalence to predicate devices | "The number of components, sizing, and all dimensions are identical to the predicate." "The results of testing indicate 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." |
| Material compatibility/performance | "Titanium alloy material has been selected to provide the surgeon with an alternate material to treat patients with nickel allergies." (Implied acceptance for patients with cobalt alloy material sensitivity). |
| Mechanical integrity (e.g., taper locking) | Test Conducted: Torsional separation of tapers. (The document states this test was performed, implying the device met internal acceptance criteria for taper integrity, though specific values are not provided in this summary.) |
| Wear characteristics | "The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy." (This is a caveat rather than a direct performance claim, acknowledging inferior wear for the titanium compared to cobalt, but still implying acceptance for its specific indication in material-sensitive patients.) |
Detailed Study Information (Not applicable/Not provided in this document type):
As noted, this document is a 510(k) summary demonstrating substantial equivalence, not a clinical study report with detailed performance data against specific acceptance criteria. Therefore, the following information is not present:
- Sample sizes used for the test set and the data provenance: Not provided for this type of submission which relies on non-clinical testing for substantial equivalence. No clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no clinical test set requiring expert ground truth for this submission.
- Adjudication method for the test set: Not applicable, as there was no clinical test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an orthopedic implant, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "No clinical data submitted." For non-clinical tests (like torsional separation), the "ground truth" would be engineering specifications and predicate device performance.
- The sample size for the training set: Not applicable. This device is an orthopedic implant, not an AI/algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
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 S. Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K131353
Trade/Device Name: Comprehensive® Reverse Shoulder - Titanium Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, PAO Dated: August 27, 2013 Received: August 29, 2013
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of October 8, 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, listing 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 of medical
{1}------------------------------------------------
Page 2 - Ms. Patricia S. 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.goy/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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): __ K131353
Device Name: Comprehensive® Reverse Shoulder - Titanium Glenosphere
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.
Titanium olenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
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 Macro Bond® 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the letters connected and enclosed in a rectangular shape. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
OCT 08 2013
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) 372-1683 | |
| Establishment Registration Number | 1825034 | |
| Name of contact person | Patricia S. BeresSenior Regulatory SpecialistBiomet Manufacturing Corp. | |
| Date prepared | October 8, 2013 | |
| NAME OF DEVICE | ||
| Trade name | Comprehensive® Reverse Shoulder - TitaniumGlenosphere | |
| Common name | Glenosphere prosthesis | |
| Classification name | Regulation | Product Code |
| Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis | 21 CFR 888.3660 | KWS |
| Shoulder joint metal/polymer (+additive) semi-constrained cemented prosthesis | 21 CFR 888.3660 | PAO |
| Classification panel | Orthopedics | |
| Legally marketed device(s) to whichequivalence is claimed | Comprehensive® Reverse Shoulder (K080642, K120121)BioModular® Shoulder System (K030710, K093803) | |
| Reason for 510(k) submission | New device | |
| Device description | The Titanium Alloy Glenosphere Prosthesis consistsof a series of various sized modular glenospheres withvariable offset between 0.5mm and 4.5 mm. Titaniumalloy material has been selected to provide thesurgeon with an alternate material to treat patientswith nickel allergies. Each modular glenosphereconsists of a "head" and a taper adaptor. The taperadaptor is impacted into the head in a certain positionto achieve the desired amount of offset. The systemcan be used with Biomet's Comprehensive® ReverseShoulder System or Biomet's BioModular® ReverseShoulder System. |
టింపిగ్రామం నుండి 100 కి.మీ. దూరంలో
గ్రామం నుండి 100 కి.మీ. దూరంలో ఉంది.
మూలాలు విద్యా సంస్థ బస్సులు గ్రామం నుండి 10 కి.మీ. దూరంలో ఉన్నాయి. వైద్యశాల సంఖ్య 2017 100000000
Shipping Address:
56 East Beil Drive Warsaw, IN 46587
{4}------------------------------------------------
K131353 (2/2)
.
.
・
510(k) Summary
Comprehensive® Reverse Shoulder – Titanium Glenosphere Page 2 of 2
| Indicationsfor use | Biomet® Comprehensive Reverse Shoulder products are indicated for use in patientswhose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/orpreviously failed shoulder joint replacement with a grossly deficient rotator cuff. Thepatient must be anatomically and structurally suited to receive the implants and afunctional deltoid muscle is necessary. |
|---|---|
| The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision totalshoulder replacement for the relief of pain and significant disability due to gross rotatorcuff deficiency. | |
| Titanium glenospheres are intended for patients with colbalt alloy material sensitivity. Thewear of these devices has not been tested but, based on pin on disk testing, the wear rateis inferior to that of cobalt alloy glenospheres. A cobalt alloy glenosphere is therecommended component for reverse shoulder arthroplasty patients without materialsensitivity to cobalt alloy. | |
| Glenoid components with Hydroxyapatite (HA) coating applied over the porous coatingare indicated only for uncemented biological fixation applications. The Glenoid Baseplatecomponents are intended for cementless application with the addition of screw fixation. | |
| Interlok finish humeral stems are intended for cemented use and the MacroBond coatedhumeral stems are intended for press-fit or cemented applications. Humeral componentswith porous coated surface coating are indicated for either cemented or uncementedbiological fixation applications. | |
| The device is a single-use implant. | |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE | |
| The number of components, sizing, and all dimensions are identical to the predicate. |
| PERFORMANCE DATA | |
|---|---|
| Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Torsional separation of tapers | |
| 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 indicate 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. |
.
§ 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.”