(99 days)
Not Found
No
The document describes a mechanical implant for shoulder replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, a reverse shoulder replacement system, is indicated for the relief of pain and significant disability due to gross rotator cuff deficiency, which directly addresses a medical condition to restore normal function.
No
This device is a shoulder joint replacement system, not a device used to identify a medical condition or disease.
No
The device description clearly states it is a total shoulder replacement system, which involves physical implants (ball, polyethylene bearing surface, glenoid components, humeral stems). This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Comprehensive® Reverse Shoulder is a surgical implant intended for total shoulder replacement. It is physically implanted into the patient's body to replace a damaged joint.
- Intended Use: The intended use is to relieve pain and disability in patients with specific shoulder conditions by replacing the joint. This is a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
The provided information clearly describes a medical device used for surgical treatment, not for testing biological samples.
N/A
Intended Use / 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.
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.
Product codes
PHX, PAO, KWS
Device Description
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.
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
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)
Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence
Environmental Stress Cracking Testing
Small punch Testing
Tensile Testing per ASTM F648
Summary of 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 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.
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
§ 888.3660 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and 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 Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46580
Re: K121183
Trade/Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, PAO, KWS Dated: April 13, 2012 Received: May 8, 2012
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of July 26, 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, 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 (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/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 ·
KIZII! 510(k) Number (if known):
Device Name: Comprehensive® Reverse Shoulder - E1® Polyethylene Claims
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.
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.
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)
Asif
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121183
Page 1 of 1
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JUL 26 2012
Image /page/3/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo is a stylized version of the word "BIOMET" with the letters connected and enclosed in a rectangular border. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The number K121183 is written in the upper right corner.
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 | 1825034 |
| Registration Number | |
| Name of contact person | Patricia Sandborn Beres |
| Senior Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Date prepared | June 14, 2012 |
| NAME OF DEVICE | |
| Trade or proprietary | |
| name | Comprehensive® Reverse Shoulder - E1® Polyethylene Claims |
| Common or usual name | Shoulder Prosthesis |
| Classification name | Shoulder joint, metal/polymer, semi-constrained, cemented |
| prosthesis | |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3660 |
| Product Code(s) | KWS, PAO |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Comprehensive® Reverse Shoulder System - K080642 |
| Comp. Reverse Shoulder - E1® Humeral Bearings - K113121 | |
| Reason for 510(k) | |
| submission | Claims language . |
| Device description | 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. | |
| Intended use of the | |
| device | Shoulder Replacement |
| 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.
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. |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE HUMERAL BEARING
COMPARED TO THE PREDICATE | |
| The devices contained in this 510(k) are identical in material, dimensions, and attachment methods
to the devices contained in the predicate Comprehensive® Reverse Shoulder System 510(k)
submissions, K080642 and K113121 | |
| PERFORMANCE DATA | |
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Environmental Stress Cracking Testing | |
| Small punch Testing | |
| Tensile Testing per ASTM F648 | |
| Summary of 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 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. | |
Matiing Address:
P.O. Box 5B7
Warbaw, IN 4E551-0587 Tod Fred: 800.346.9500 0:00:00:574.207.6639
Max Fax: 574.267.8137
www.biomst.com Shipping Addross: 53 East Bell Drivo Via:saw, IN 46582
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:
5
K12-1183
CLAIMS FOR E1® ANTIOXIDANT INFUSED TECHNOLOGY*
Claim 1:
E1® Antioxidant Infused Technology prevents oxidative degradation of polyethylene. Environmental stress crack testing was conducted by cyclically loading GUR1020 and GUR1050 E1® test specimens in an air atmosphere maintained at 80℃ for 5 weeks. Testing was completed per the literature (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684). E1® specimens showed no evidence of environmental stress cracking and infrared spectroscopy showed no detectable oxidation in the loaded or unloaded samples (oxidation indices 0.05) in ultimate load , ultimate tensile strength, or yield strength after accelerated aging for either the E1® GUR1050 or the E1® GUR1020 material. Ultimate load was measured by small punch testing per ASTM F2183; ultimate tensile strength and yield strength were measured by tensile testing per ASTM D638; Accelerated aging was performed per ASTM F2003 (70°C and 5 atm of oxygen for 14 days). The ultimate load for the E1® GUR1020 material before and after accelerated aging was 97.2±6.4N and 100.0±5.0N respectively. The ultimate tensile strength for the E1® GUR1020 material before and after accelerated aging was 45.8±1.6 and 46.1±2.9 MPa respectively. The yield strength for the E1® GUR1020 material before and after accelerated aging was 22.6±0.2 and 22.8±0.3 MPa respectively. The ultimate load for the E1® GUR1050 material before and after accelerated aging was 105.0±5.5N and 115.0±3.2N respectively. The ultimate tensile strength for the E1® GUR1050 material before and after accelerated aging was 43±3 and 43±2 MPa respectively. The vield strength for the E1® GUR1050 material before and after accelerated aging was 24.2±0.2 and 24.4±0.2 MPa respectively. E1® samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.
- Note: E10 Antioxidant Infused Technology may be used interchangeably with any of the following: E19 Antioxidant Infused Bearings, E10 Antioxidant Infused Material, E10 material, E1® technology, E1® bearings, E1® liners, E1® acetabular liners, E1° Humeral Bearings and E1®