(116 days)
No
The summary describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an Anatomical Shoulder Combined System, which includes components for shoulder arthroplasty (joint replacement) to treat conditions like arthritis and avascular necrosis. These are medical conditions that impair joint function and cause pain, and the device is intended to alleviate these symptoms and restore function, hence classifying it as a therapeutic device.
No
The device description clearly states it is an "Anatomical Shoulder Combined System" consisting of various components (humeral stems, heads, glenoids, adaptors) used in shoulder arthroplasty procedures. The "Intended Use" section describes its application for advanced destruction of the shoulder joint due to various conditions, indicating a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description clearly outlines multiple physical components made of various materials (Co-Cr-Mo, titanium alloy, UHMWPE, Trabecular Metal). This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a system of components (humeral stems, heads, glenoids, adaptor) intended for use in shoulder arthroplasty, which is a surgical procedure to replace the shoulder joint.
- Intended Use: The intended use is for the advanced destruction of the shoulder joint due to various conditions, which is treated through surgical intervention, not by analyzing samples outside the body.
The device is an implantable medical device used in vivo (within the body) during surgery, not an in vitro diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
Advanced destruction of the shoulder joint resulting from:
- Omarthrosis. ◆
- Rheumatoid arthritis
- Post-traumatic arthritis ●
- Avascular necrosis of the humeral head .
- Cuff-tear arthropathy (BF heads with heights of 27mm or greater) .
- Conditions following earlier operations (including revision shoulder arthroplasty). .
The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
- Anatomical Shoulder Standard Cemented Humeral Stem. .
- Anatomical Shoulder Revision Stem. t
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
-
Anatomical Shoulder Standard Uncemented Stem. ●
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: -
. Anatomical Shoulder Fracture Stem.
-
Anatomical Shoulder Fracture Long Stem. ●
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
-
Bigliani/Flatow Glenoid (pegged and keeled).
- Trabecular Metal Glenoid. .
Product codes
KWT, KWS, HSD
Device Description
The Anatomical Shoulder (AS) Combined System consists of the following:
- AS Humeral Stem (cemented or . uncemented)
- AS Fracture Humeral Stem
- Bigliani/Flatow Head .
- Bigliani/Flatow Gleniod .
- Trabecular Metal (TM) Glenoid .
- AS Bigliani/Flatow (AS B/F) Adaptor .
The AS B/F Adaptor is a new product designed to be used with the humeral stems of the Anatomical Shoulder System and Anatomical Shoulder Fracture System and with any humeral head of the Bigliani/Flatow (BF) System in a conventional hemi or total shoulder arthroplasty procedure. The B/F humeral heads are used with existing UHMWPE B/F glenoids and TM glenoids manufactured from Trabecular Metal and UHMWPE. AS cemented humeral stems are manufactured from Protasul -1 (Co-Cr-Mo); the uncemented and fracture stems from Protasul-100 (titanium alloy). The B/F heads are manufactured from Zimaloy® (Co-Cr-Mo). Collectively, these components are identified as the Anatomical Shoulder Combined System.
The Adaptor features two taper interfaces, one connecting to the Anatomical Shoulder humeral stems and the other connecting to the Bigliani/Flatow humeral heads. The proximal taper of the adaptor (connecting to the Bigliani/Flatow heads) is identical to the male taper geometry from the predicate Bigliani/Flatow humeral stems. The distal taper of the adaptor (connecting to the Anatomical Shoulder humeral stem) is a male oval taper, identical to the oval taper of the predicate Anatomical Shoulder Ball-Taper component. Both the AS B/F Adaptor and the predicate AS Ball-Taper component are manufactured from Protasul-100, a forged titanium alloy.
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
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing and/or analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing and/or analyses included: Evaluation of Loading Conditions, Fatigue Analysis, Fretting Corrosion, Assembly Strength Test.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Anatomical Shoulder with Removable Head, K030259, Anatomical Shoulder Fracture System, K062029, Bigliani/Flatow® The Complete Shoulder System, K982981, Trabecular Metal Glenoid, K022377
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation 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, 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K103404 (1/4)
Image /page/0/Picture/1 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter 'Z' inside of a circle. Below the circle is the word 'zimmer' in lowercase letters.
·
| Summary of Safety and Effectiveness | MAR 15 2011 |
|---|---|
| Sponsor: | Zimmer GmbH |
| SulzerAllee 8 | |
| CH-8404 Winterthur, Switzerland | |
| Contact Person: | Jason Heckaman |
| Associate Manager, Regulatory Affairs | |
| Telephone: (574) 371-8675 | |
| Fax: (574) 372-4605 | |
| Date: | February 25, 2011 |
| Trade Name: | Anatomical Shoulder™ Combined System |
| Product Code / Device: | KWT - Prosthesis, Shoulder, Non-constrained, |
| Metal/Polymer Cemented | |
| KWS - Prosthesis, Shoulder, Semi-constrained, | |
| Metal/Polymer Cemented | |
| HSD - Prosthesis, Shoulder, Hemi-, Humeral, | |
| Metallic Uncemented | |
| Regulation Number / Description: | 21 CFR § 888.3650 - Shoulder joint metal/polymer |
| non-constrained cemented prosthesis. | |
| 21 CFR § 888.3660 - Shoulder joint metal/polymer | |
| semi-constrained cemented prosthesis | |
| 21 CFR § 888.3690 - Shoulder joint humeral (hemi- | |
| shoulder) metallic uncemented prosthesis. | |
| Predicate Device: | Anatomical Shoulder with Removable Head, |
| manufactured by Zimmer GmbH, K030259, cleared | |
| 04/24/2003 | |
| Anatomical Shoulder Fracture System, | |
| manufactured by Zimmer GmbH, K062029, cleared | |
| October 31, 2006) | |
| Bigliani/Flatow® The Complete Shoulder System, | |
| manufactured by Zimmer, Inc., K982981, cleared | |
| 12/17/1998; Trabecular Metal Glenoid, | |
| manufactured by Zimmer TMT, K022377, cleared | |
| 12/10/2002 |
--
1
Device Description:
The Anatomical Shoulder (AS) Combined System consists of the following:
- AS Humeral Stem (cemented or . uncemented)
- AS Fracture Humeral Stem �
- Bigliani/Flatow Head .
- Bigliani/Flatow Gleniod .
- Trabecular Metal (TM) Glenoid .
- AS Bigliani/Flatow (AS B/F) Adaptor .
The AS B/F Adaptor is a new product designed to be used with the humeral stems of the Anatomical Shoulder System and Anatomical Shoulder Fracture System and with any humeral head of the Bigliani/Flatow (BF) System in a conventional hemi or total shoulder arthroplasty procedure. The B/F humeral heads are used with existing UHMWPE B/F glenoids and TM glenoids manufactured from Trabecular Metal and UHMWPE. AS cemented humeral stems are manufactured from Protasul -1 (Co-Cr-Mo); the uncemented and fracture stems from Protasul-100 (titanium alloy). The B/F heads are manufactured from Zimaloy® (Co-Cr-Mo). Collectively, these components are identified as the Anatomical Shoulder Combined System.
The Adaptor features two taper interfaces, one connecting to the Anatomical Shoulder humeral stems and the other connecting to the Bigliani/Flatow humeral heads. The proximal taper of the adaptor (connecting to the Bigliani/Flatow heads) is identical to the male taper geometry from the predicate Bigliani/Flatow humeral stems. The distal taper of the adaptor (connecting to the Anatomical Shoulder humeral stem) is a male oval taper, identical to the oval taper of the predicate Anatomical Shoulder Ball-Taper component. Both the AS B/F Adaptor and the predicate AS Ball-Taper component are manufactured from Protasul-100, a forged titanium alloy.
Advanced destruction of the shoulder joint resulting from:
- Omarthrosis. ●
- Rheumatoid arthritis .
Intended Use:
2
- Post-traumatic arthritis
- Avascular necrosis of the humeral head .
- Cuff-tear arthropathy (BF heads with heights of . 27mm or greater)
- Conditions following earlier operations . (including revision shoulder arthroplasty).
The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
- Anatomical Shoulder Standard Cemented t Humeral Stem.
- Anatomical Shoulder Revision Stem. .
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
-
Anatomical Shoulder Standard Uncemented . Stem.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: -
Anatomical Shoulder Fracture Stem. .
-
Anatomical Shoulder Fracture Long Stem. .
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
- Bigliani/Flatow Glenoid (pegged and keeled). .
- Trabecular Metal Glenoid. .
Comparison to Predicate Device:
The proposed Anatomical Shoulder Combined System consists of some of the same devices as the referenced predicates, including: Anatomical Shoulder humeral stems, Bigliani/Flatow humeral heads and glenoids, and the Trabecular Metal glenoid. Additionally, the new AS B/F component has identical proximal taper geometry to that of the predicate Bigliani/Flatow humeral stem and identical distal taper geometry to that of the predicate Anatomical Shoulder Ball-Taper component. Collectively, the proposed system has the same intended use, has similar performance
3
characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing and/or analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing and/or analyses included: Evaluation of Loading Conditions, Fatigue Analysis, Fretting Corrosion, Assembly Strength Test.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircles the eagle. The text is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer GmbH % Zimmer. Inc. Mr. Jason Heckaman P.O Box 708 Warsaw, Indiana 46581-0708
MAR 1 5 2011
Re: K103404
Trade/Device Name: Anatomical Shoulder™ Combined System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWT, KWS, HSD Dated: February 25, 2011 Received: February 28, 2011
Dear Mr. Heckaman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Mr. Jason Heckaman
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm117800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21)FP, 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Aty B. R.h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K103404
Device Name:
Anatomical Shoulder™ Combined System
Indications for Use:
Advanced destruction of the shoulder joint resulting from:
- Omarthrosis. ◆
- Rheumatoid arthritis �
- Post-traumatic arthritis ●
- Avascular necrosis of the humeral head .
- Cuff-tear arthropathy (BF heads with heights of 27mm or greater) .
- Conditions following earlier operations (including revision shoulder arthroplasty). .
The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use:
- Anatomical Shoulder Standard Cemented Humeral Stem. .
- Anatomical Shoulder Revision Stem. t
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
-
Anatomical Shoulder Standard Uncemented Stem. ●
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: -
. Anatomical Shoulder Fracture Stem.
-
Anatomical Shoulder Fracture Long Stem. ●
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
-
Bigliani/Flatow Glenoid (pegged and keeled).
- Trabecular Metal Glenoid. .
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
M. Melkerson
(Division Sign-off)
Page 1 of 1
(División Sign-pn.
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1
510(k) Number
い