Tecomet Global Unite Short Stem Instrumentation

K211553 · Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. · PHX · Aug 4, 2021 · Orthopedic

Device Facts

• Record ID: K211553
• Device Name: Tecomet Global Unite Short Stem Instrumentation
• Applicant: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Aug 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2

Intended 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.

Device Story

Surgical instrumentation set for implantation of DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder; includes humeral stem brosteotomes (8mm-16mm), stem wrench, 145°/155° proximal reaming guides, and bullet tip reamers. Used by orthopedic surgeons in clinical/OR settings to prepare humeral bone for implant placement. Instruments facilitate reaming, sizing, and positioning of shoulder prosthesis. Reusable devices require user sterilization via prevacuum steam. Benefits include precise bone preparation for short-stem shoulder arthroplasty.

Clinical Evidence

Bench testing only. Includes sterilization efficacy (AAMI ST77, ISO 17665-1) and dry time validation. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Design validation conducted via cadaver testing to confirm acceptable performance for anatomic and reverse shoulder preparation.

Technological Characteristics

Material: 17-4 PH SST Stainless Steel. Reusable manual surgical instruments. Sterilization: Prevacuum steam (132°C, 4-minute cycle). Includes sterilization tray (cleared under K012105). No electronic components or software.

Indications for Use

Indicated for use as surgical instrumentation to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder in patients undergoing shoulder arthroplasty.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• DePuy GLOBAL UNITE Platform Shoulder System (K170748)
• DePuy Delta Xtend Reverse Shoulder System (K192855)

Reference Devices

• Polyvac Surgical Instrument Delivery System (K012105)
• DePuy GLOBAL UNITE Short Stem Shoulder System (K202098)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">X</span> 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.<br>3724 North State Road 15<br>Warsaw, Indiana 46582<br>[phone] |
|----|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | David C. Furr<br>8708 Capehart Cove<br>Austin, Texas 78733<br>512-906-9654 |
| 3. | Product: | Tecomet Global Unite Short Stem Instrumentation Product<br>codes: PHX - Class II (21 CFR 888.3660)<br>KWS - Class II (21 CFR 888.3660)<br>HSD - Class II (21 CFR 888.3960) |
| 4. | Common/Classification<br>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.

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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 of<br>Comparison | 510(k) Device:<br>Tecomet Global Unite<br>Short Stem<br>Instrumentation | Predicate Devices:<br>DePuy GLOBAL UNITE<br>Platform Shoulder System<br>(K170748)<br>DePuy Delta Xtend Reverse<br>Shoulder System (K192855) | Comparison |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation<br>and Product<br>Classification<br>Code | PHX, KWS, HSD - Class II<br>(21 CFR 888.3660 & 21<br>CFR 888.3690) | PHX, KWS, HSD - Class II (21<br>CFR 888.3660 & 21 CFR<br>888.3690) | Same |
| Indications<br>for Use | The Tecomet Global Unite<br>Short Stem Instrumentation<br>(GUSS) are intended to be<br>used to implant the DePuy<br>GLOBAL UNITE Shoulder<br>System Short Stem Shoulder,<br>in accordance with its cleared<br>indications for use and<br>contraindications. | Refer to K170748 & K192855<br><br>All predicate device indications<br>are shoulder arthroplasty | Subject device is not for implantation but<br>is similar to instrumentation in the<br>predicates.<br><br>Predicate shoulder system indications do<br>not detail instrumentation. |
| Principal<br>Material of<br>Construction<br>(instruments<br>only) | The Tecomet Global Unite<br>Short Stem Instrumentation<br>(GUSS) is all manufactured<br>from 17-4 PH SST Stainless<br>Steel | 17-4 PH SST Stainless Steel | Same |
| Humeral<br>Component<br>Instrument<br>Configuration | Bullet tip reamers,<br>brosteotomes, reaming<br>guides, stem wrench and<br>instrument tray | Bullet tip reamers, brosteotomes,<br>reaming guides, stem wrench and<br>instrument tray | Configuration is identical; subject devices<br>include short-stem sizes: 145° reaming<br>guide predicates were included in<br>K170748 and 155° reaming guide<br>predicates were under K192855. |
| Sterilization | Prevacuum Steam<br>4 minute cycle 132°C | Prevacuum Steam<br>4 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<br>(as applicable) | Acceptance<br>Criteria | Test<br>Result |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----------------|
| Pre-vacuum sterilization efficacy<br>3 minutes at 132°C | AAMI ST77 Containment Devices for<br>Reusable Medical Device Sterilization<br>ISO 17665-1 Sterilization of Health Care<br>Products – Moist Heat – Part 1<br>Requirements for the Development,<br>Validation, and Routine Control of a<br>Sterilization Process for Medical Devices | 10⁻⁶ SAL | PASSED |
| Pre-vacuum dry time<br>3 minutes | AAMI ST77 Containment Devices for<br>Reusable Medical Device Sterilization<br>ISO 17665-1 Sterilization of Health<br>Care Products - Moist Heat - Part 1<br>Requirements for the Development,<br>Validation, and Routine Control of a<br>Sterilization Process for Medical<br>Devices | Establish<br>Minimum Dry<br>Time | 40 minutes |
| Pre-vacuum dry time<br>4 minutes | AAMI ST77 Containment Devices for<br>Reusable Medical Device Sterilization<br>ISO 17665-1 Sterilization of Health<br>Care Products - Moist Heat - Part 1<br>Requirements for the Development,<br>Validation, and Routine Control of a<br>Sterilization Process for Medical Devices | Establish<br>Minimum Dry<br>Time | 40 minutes |
| Design Validation | N/A design validation cadaver testing | Acceptable<br>performance for<br>reverse and<br>anatomic<br>shoulder<br>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).