(86 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 is a reverse shoulder replacement system designed to relieve pain and disability due to gross rotator cuff deficiency, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a total shoulder replacement system, not a diagnostic tool. Its purpose is to replace a damaged joint, not to identify or analyze medical conditions.
No
The device description clearly indicates it is a physical implant (shoulder replacement components) and discusses materials and mechanical properties, which are characteristic of hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a shoulder prosthesis and how it functions mechanically within the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties like fatigue strength and material properties of the implant, which are relevant to the function of a surgical device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
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, 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
Prescription Use
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: Non-Clinical Tests (Mechanical Testing)
Sample Size: Not explicitly stated, but results given for multiple categories of components.
Standalone Performance: The median fatigue strength was greater for the modified devices compared to the predicate device. For polyethylene properties, "All properties exceed the requirements of ASTM F-648".
Key Results: The results of mechanical testing indicated the 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. No clinical data was necessary for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Comprehensive® Reverse Shoulder 510(k) K080642
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 & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a person embracing a bird, representing care and protection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
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 46581-0857
Re: K113069
Trade/Device Name: Comprehensive® Reverse Shoulder Humeral Tray 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: October 13, 2011 Received: October 17, 2011
Dear Ms. Beres:
This letter corrects our substantially equivalent letter of January 11, 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 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): KI (3009
Device Name: Comprehensive® Reverse Shoulder Humeral Tray
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 Baseblate 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 _ X (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)
Elizabeth PM
Soc (Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
3
113069
MANUFACTURING CORP.
-- J
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 46581-0857 | ||
| 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 | October 13, 2011 | |
| NAME OF DEVICE | ||
| Trade or proprietary | ||
| name | Comprehensive® Reverse Shoulder Humeral Tray | |
| 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 | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | Comprehensive® Reverse Shoulder | |
| 510(k) K080642 | ||
| Reason for 510(k) submission | Product improvement | |
| 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. | |
| Indications for use.
(continued) | 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 DEVICE COMPARED TO THE | | |
| PREDICATE | | |
| Characteristic | Modified Device | Comprehensive® Reverse Shoulder
510(k) K080642 |
| Humeral Tray | Sizes: 44mm (std, +5mm, +10mm)
Finish: No change.
Material: Ti-6Al-4V and Co-Cr-Mo
Attachment: No change
Angle: No change | Sizes: 44 & 49mm (std, +5mm, +10mm)
Finish: Smooth
Material: Ti-6Al-4V
Attachment: Taper
Angle: 45° |
| Humeral Bearing | No Changes | UHMWPE:(ArComXL®, 1020 E-Poly™)
31, 36, 41mm
Std, Std +3mm, Retentive:+3mm
Ringloc® snap ring |
| Glenoid.Baseplate | No Changes | Diameter: 28mm
Surface Finish: PPS/HA
Material: Ti-6Al-4V
Fixation: Screws |
| Glenoid Screws | Styles: Fixed/Locking, Fixed Non-
Locking
Material: No change
Diameter: No change
Lengths: No change
Drive Slot: 2.5 Hex | Styles: Fixed/Locking, Fixed Non-Locking,
Variable Locking
Material: Ti-6Al-4V
Diameter: 4.75mm
Lengths: 15-45mm
Drive Slot: Hexalobular |
| Glenosphere | No Changes | Diameters: 31, 36, 41mm,
Offset: Std, +3mm, +6mm
Material. Co-Cr-Mo
Attachment to Base: Taper |
| PERFORMANCE DATA | | |
| Summary Of Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | | |
| Performance Test Summary-New Device | | |
| Characteristic | Standard/Test/FDA Guidance | Results:Summary |
| Fatigue Strength | None | The median fatigue strength was
greater for the modified devices
compared to the predicate device. |
| Polyethylene Properties | ASTM F-648 | All properties exceed the
requirements of ASTM F-648 |
| Summary of clinical tests conducted for determination of substantial equivalence and/or of
clinical information | | |
| No clinical data submitted | | |
និង Box Address:
ព្រះជាប្រជាជន និងប្រជាជនជាតិនារី បានស្រី
ប្រជាជនជាតិ និងប្រជាជនជាតិនាំ ប្រជាជនជាតិ
ប្រចាំក្រោយ ប្រាសាទនេះ ប្រចាំបន់ក្រោយប្រជាជន
ប្រចាំបន់ប្រកាស ប្រ
Shipping Address:
56 East Bed Onice
Warsaw, IN 46582
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| K11 3069
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2 & 3 Page
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KH3069
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
No clinical data was necessary for a determination of substantial'equivalence.
The results of mechanical testing indicated the 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.
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