(77 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Tecomet Global Unite Short Stem Instrumentation, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Type of Testing | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|
| Pre-vacuum sterilization efficacy | 10⁻⁶ SAL (Sterility Assurance Level) | PASSED |
| Pre-vacuum dry time (3 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Pre-vacuum dry time (4 minutes) | Establish Minimum Dry Time (specific time not explicitly stated as acceptance criteria, but as a goal) | 40 minutes |
| Design Validation | Acceptable performance for reverse and anatomic shoulder preparation | PASSED |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the sterilization efficacy, dry time, or design validation testing. Specifically:
- Sterilization and Dry Time: No sample size is mentioned for these tests.
- Design Validation: "N/A design validation cadaver testing" is mentioned, implying cadavers were used, but the quantity is not specified.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests.
4. Adjudication Method
- The document does not specify any adjudication method for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is surgical instrumentation, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
- This question is not applicable. The device is surgical instrumentation, not an algorithm or software.
7. Type of Ground Truth Used
- Sterilization Efficacy: The ground truth is the demonstration of a 10⁻⁶ SAL, which is a microbiological standard.
- Pre-vacuum Dry Time: The ground truth is the established minimum dry time achieved necessary for effective sterilization.
- Design Validation: The ground truth is "acceptable performance" during cadaver testing, likely assessed by surgeons or qualified personnel evaluating the functionality and usability of the instruments in a simulated surgical environment.
8. Sample Size for the Training Set
- This question is not applicable as the device is surgical instrumentation and does not involve a training set as would be found in machine learning models.
9. How Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this type of device.
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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
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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
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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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510(k) Summary
Date: July 29, 2021
| 1. | Submitted By: | Symmetry Medical Manufacturing Inc. DBA Tecomet, Inc.3724 North State Road 15Warsaw, Indiana 46582(574) 267-8700 |
|---|---|---|
| 2. | Contact: | David C. Furr8708 Capehart CoveAustin, Texas 78733512-906-9654 |
| 3. | Product: | Tecomet Global Unite Short Stem Instrumentation Productcodes: PHX - Class II (21 CFR 888.3660)KWS - Class II (21 CFR 888.3660)HSD - Class II (21 CFR 888.3960) |
| 4. | Common/ClassificationName: | 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.
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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 ofComparison | 510(k) Device:Tecomet Global UniteShort StemInstrumentation | Predicate Devices:DePuy GLOBAL UNITEPlatform Shoulder System(K170748)DePuy Delta Xtend ReverseShoulder System (K192855) | Comparison |
|---|---|---|---|
| Regulationand ProductClassificationCode | PHX, KWS, HSD - Class II(21 CFR 888.3660 & 21CFR 888.3690) | PHX, KWS, HSD - Class II (21CFR 888.3660 & 21 CFR888.3690) | Same |
| Indicationsfor Use | The Tecomet Global UniteShort Stem Instrumentation(GUSS) are intended to beused to implant the DePuyGLOBAL UNITE ShoulderSystem Short Stem Shoulder,in accordance with its clearedindications for use andcontraindications. | Refer to K170748 & K192855All predicate device indicationsare shoulder arthroplasty | Subject device is not for implantation butis similar to instrumentation in thepredicates.Predicate shoulder system indications donot detail instrumentation. |
| PrincipalMaterial ofConstruction(instrumentsonly) | The Tecomet Global UniteShort Stem Instrumentation(GUSS) is all manufacturedfrom 17-4 PH SST StainlessSteel | 17-4 PH SST Stainless Steel | Same |
| HumeralComponentInstrumentConfiguration | Bullet tip reamers,brosteotomes, reamingguides, stem wrench andinstrument tray | Bullet tip reamers, brosteotomes,reaming guides, stem wrench andinstrument tray | Configuration is identical; subject devicesinclude short-stem sizes: 145° reamingguide predicates were included inK170748 and 155° reaming guidepredicates were under K192855. |
| Sterilization | Prevacuum Steam4 minute cycle 132°C | Prevacuum Steam4 minute cycle 132°C | Same |
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510(k) Premarket Notification Tecomet Global Unite Short Stem Instrumentation
Summary of Non-Clinical Testing:
| Type of Testing | Primary Standard(s) Used(as applicable) | AcceptanceCriteria | TestResult |
|---|---|---|---|
| Pre-vacuum sterilization efficacy3 minutes at 132°C | AAMI ST77 Containment Devices forReusable Medical Device SterilizationISO 17665-1 Sterilization of Health CareProducts – Moist Heat – Part 1Requirements for the Development,Validation, and Routine Control of aSterilization Process for Medical Devices | 10⁻⁶ SAL | PASSED |
| Pre-vacuum dry time3 minutes | AAMI ST77 Containment Devices forReusable Medical Device SterilizationISO 17665-1 Sterilization of HealthCare Products - Moist Heat - Part 1Requirements for the Development,Validation, and Routine Control of aSterilization Process for MedicalDevices | EstablishMinimum DryTime | 40 minutes |
| Pre-vacuum dry time4 minutes | AAMI ST77 Containment Devices forReusable Medical Device SterilizationISO 17665-1 Sterilization of HealthCare Products - Moist Heat - Part 1Requirements for the Development,Validation, and Routine Control of aSterilization Process for Medical Devices | EstablishMinimum DryTime | 40 minutes |
| Design Validation | N/A design validation cadaver testing | Acceptableperformance forreverse andanatomicshoulderpreparation | 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).
N/A