(77 days)
No
The document describes surgical instrumentation made of stainless steel for implanting a shoulder system. There is no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is described as "surgical instrumentation" for implanting a shoulder system, not the therapeutic implant itself.
No
The device is described as surgical instrumentation used to implant a shoulder system, and the description focuses on its materials, components, and use in surgery, rather than on diagnosing conditions.
No
The device description explicitly states that the device is surgical instrumentation made from stainless steel, which are physical hardware components.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Tecomet Global Unite Short Stem Instrumentation (GUSS) is "surgical instrumentation" intended for use in implanting a shoulder system. It is used during surgery, not for testing samples outside the body.
- Intended Use: The intended use is to "implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder." This is a surgical procedure, not a diagnostic test.
The device is a surgical instrument used in shoulder arthroplasty, which is a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.
Product codes
PHX, KWS, HSD
Device Description
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System).
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Type of Testing: Pre-vacuum sterilization efficacy 3 minutes at 132°C. Primary Standard(s) Used: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products – Moist Heat – Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Acceptance Criteria: 10⁻⁶ SAL. Test Result: PASSED.
Type of Testing: Pre-vacuum dry time 3 minutes. Primary Standard(s) Used: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products - Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Acceptance Criteria: Establish Minimum Dry Time. Test Result: 40 minutes.
Type of Testing: Pre-vacuum dry time 4 minutes. Primary Standard(s) Used: AAMI ST77 Containment Devices for Reusable Medical Device Sterilization ISO 17665-1 Sterilization of Health Care Products - Moist Heat - Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Acceptance Criteria: Establish Minimum Dry Time. Test Result: 40 minutes.
Type of Testing: Design Validation. Primary Standard(s) Used: N/A design validation cadaver testing. Acceptance Criteria: Acceptable performance for reverse and anatomic shoulder preparation. Test Result: PASSED.
Cytotoxicity testing per ISO 10993-5, Irritation testing per ISO 10993-10, Sensitization testing per ISO 10993-10 was conducted and justifications for not performing acute systemic toxicity and material mediated pyrogenicity testing were provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue.
Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc. % David Furr Consultant FDC Services LLC 8708 Capehart Cove Austin, Texas 78733
Re: K211553
Trade/Device Name: Tecomet Global Unite Short Stem Instrumentation Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD Dated: June 8, 2021 Received: June 10, 2021
Dear David Furr:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
August 4, 2021
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211553
Device Name
Tecomet Global Unite Short Stem Instrumentation
Indications for Use (Describe)
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Date: July 29, 2021
| 1. | Submitted By: | Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc.
3724 North State Road 15
Warsaw, Indiana 46582
(574) 267-8700 |
|----|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr
8708 Capehart Cove
Austin, Texas 78733
512-906-9654 |
| 3. | Product: | Tecomet Global Unite Short Stem Instrumentation Product
codes: PHX - Class II (21 CFR 888.3660)
KWS - Class II (21 CFR 888.3660)
HSD - Class II (21 CFR 888.3960) |
| 4. | Common/Classification
Name: | Shoulder Arthroplasty Instruments |
Predicate devices: DePuy GLOBAL UNITE Platform Shoulder System K170748 DePuy Delta Xtend Reverse Shoulder System K192855
Description:
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System).
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.
4
510(k) Premarket Notification Tecomet Global Unite Short Stem Instrumentation
Indications for Use:
The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.
Comparison of Technological Characteristics:
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is substantially equivalent to the reaming, sizing and positioning instrumentation included in the GLOBAL UNITE Platform Shoulder System (K170748) and The DePuy Delta Xtend Reverse Shoulder System (K192855). The predicate devices are entire shoulder systems; however, the subject devices are only instruments. 145° reaming guide predicates were included in K170748 and 155° reaming guide predicates were under K192855.
The subject instruments and predicate instruments are made from the same material and are used in a similar fashion.
| Element of
Comparison | 510(k) Device:
Tecomet Global Unite
Short Stem
Instrumentation | Predicate Devices:
DePuy GLOBAL UNITE
Platform Shoulder System
(K170748)
DePuy Delta Xtend Reverse
Shoulder System (K192855) | Comparison |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
and Product
Classification
Code | PHX, KWS, HSD - Class II
(21 CFR 888.3660 & 21
CFR 888.3690) | PHX, KWS, HSD - Class II (21
CFR 888.3660 & 21 CFR
888.3690) | Same |
| Indications
for Use | The Tecomet Global Unite
Short Stem Instrumentation
(GUSS) are intended to be
used to implant the DePuy
GLOBAL UNITE Shoulder
System Short Stem Shoulder,
in accordance with its cleared
indications for use and
contraindications. | Refer to K170748 & K192855
All predicate device indications
are shoulder arthroplasty | Subject device is not for implantation but
is similar to instrumentation in the
predicates.
Predicate shoulder system indications do
not detail instrumentation. |
| Principal
Material of
Construction
(instruments
only) | The Tecomet Global Unite
Short Stem Instrumentation
(GUSS) is all manufactured
from 17-4 PH SST Stainless
Steel | 17-4 PH SST Stainless Steel | Same |
| Humeral
Component
Instrument
Configuration | Bullet tip reamers,
brosteotomes, reaming
guides, stem wrench and
instrument tray | Bullet tip reamers, brosteotomes,
reaming guides, stem wrench and
instrument tray | Configuration is identical; subject devices
include short-stem sizes: 145° reaming
guide predicates were included in
K170748 and 155° reaming guide
predicates were under K192855. |
| Sterilization | Prevacuum Steam
4 minute cycle 132°C | Prevacuum Steam
4 minute cycle 132°C | Same |
5
510(k) Premarket Notification Tecomet Global Unite Short Stem Instrumentation
Summary of Non-Clinical Testing:
| Type of Testing | Primary Standard(s) Used
(as applicable) | Acceptance
Criteria | Test
Result |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------|
| Pre-vacuum sterilization efficacy
3 minutes at 132°C | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health Care
Products – Moist Heat – Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices | 10⁻⁶ SAL | PASSED |
| Pre-vacuum dry time
3 minutes | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health
Care Products - Moist Heat - Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices | Establish
Minimum Dry
Time | 40 minutes |
| Pre-vacuum dry time
4 minutes | AAMI ST77 Containment Devices for
Reusable Medical Device Sterilization
ISO 17665-1 Sterilization of Health
Care Products - Moist Heat - Part 1
Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices | Establish
Minimum Dry
Time | 40 minutes |
| Design Validation | N/A design validation cadaver testing | Acceptable
performance for
reverse and
anatomic
shoulder
preparation | PASSED |
The following testing was conducted or is referenced to establish efficacy.
The Tecomet Global Unite Short Stem Instrumentation (GUSS) is identical in material to the corresponding predicate device instrumentation GLOBAL UNITE Platform Shoulder System. Cytotoxicity testing per ISO 10993-5, Irritation testing per ISO 10993-10, Sensitization testing per ISO 10993-10 was conducted and justifications for not performing acute systemic toxicity and material mediated pyrogenicity testing were provided.
Conclusion
The results of the non-clinical testing and evaluations have demonstrated that the subject devices are substantially equivalent to the predicate devices (K170748, K192855).