Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

K232414 · Total Joint Othopedics, Inc. · JWH · Sep 8, 2023 · Orthopedic

Device Facts

• Record ID: K232414
• Device Name: Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post
• Applicant: Total Joint Othopedics, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 8, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis - Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis - · Patients with failed previous surgery where pain, deformity, or dysfunction persists - · Correctable varus-valgus deformity and moderate flexion contracture - · Revision of a previously failed knee arthroplasty - · Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

Device Story

Klassic® Knee System components (Tibial Inserts, PS-Post; All Poly Tibia, PS-Post) provide prosthetic replacement for knee arthroplasty. Device serves as orthopedic implant for patients with degenerative or inflammatory joint disease, or failed prior surgery. Surgeons implant device in clinical setting during total knee replacement or revision procedures. Components function as mechanical bearing surfaces to restore joint function and alleviate pain. Device updates include additional thicknesses (18, 21, 24mm) and new PS-Post geometry for All Poly Tibia. Materials include Standard Poly (GUR 1050 UHMWPE) and Vitamin E UHMWPE (E-Link).

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated via non-clinical engineering analyses and testing: Femoral/Tibial Constraint (ASTM F1223), Contact Area/Stress (ASTM F2083), Post Fatigue, Range of Motion, Wear (ISO 14243-3), and Tibial Insert Modular Disassembly Strength (ASTM F1814). Compliance with LAL testing requirements for orthopedic implants confirmed.

Technological Characteristics

Materials: GUR 1050 UHMWPE (Standard Poly) and Vitamin E UHMWPE (E-Link). Sterilization: Ethylene Oxide (EO). Design: Tibial inserts and All Poly Tibia implants with PS-Post geometry. Standards: ASTM F1223, ASTM F2083, ASTM F1814, ISO 14243-3. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring total knee replacement due to non-inflammatory degenerative joint disease (avascular necrosis, osteoarthritis), inflammatory joint disease (rheumatoid arthritis), failed previous surgery, or revision of failed knee arthroplasty. Also indicated for patients with correctable varus-valgus deformity and moderate flexion contracture.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Klassic® Knee System (K112906)
• Klassic® Knee System (K162422)
• Klassic® Knee System (K183596)
• Tibial Inserts, PS-Max (K202740)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 8, 2023

Total Joint Othopedics, Inc. % Hollace Rhodes VP, Orthopedic Regulatory Affairs MCRA, LLC 803 7th Steet NW Floor 3 Washington. District of Columbia 20001

Re: K232414

Trade/Device Name: Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OIY Dated: August 10, 2023 Received: August 10, 2023

Dear Hollace Rhodes:

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.

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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 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 (QS) 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 medical devices and radiation-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.

# Lixin Liu -S

Lixin Liu, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232414

Device Name

Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post

Indications for Use (Describe)

The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: · Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis

- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Manufacturer: | Total Joint Orthopedics, Inc.<br>1567 E. Stratford Avenue<br>Salt Lake City, UT 84106<br>Phone: [phone] |
|---------------------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Chris Weaber<br>Director of Research and Development |
| Prepared By: | MCRA, LLC<br>803 7th Street NW, Floor 3<br>Washington, DC 20001<br>Phone: [phone] |
| Date Prepared: | August 10, 2023 |
| Device Trade Name: | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post |
| Device Common Name: | Tibial Insert and All Poly Tibia |
| Classification: | 21 CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis |
| | 21 CFR 888.3565 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained uncemented prosthesis |
| | Class II |
| Product Code: | IWH, MBH, OIY |

### Indications for Use:

The Klassic® Knee System is intended for prosthetic replacement of the following:

- Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis ●
- Patients with failed previous surgery where pain, deformity, or dysfunction persists ●
- Correctable varus-valgus deformity and moderate flexion contracture .
- Revision of a previously failed knee arthroplasty ●
- Patients who require a total knee replacement ●

The Klassic® Knee System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.

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#### Device Description:

The Klassic® Knee System is being updated with additional thicknesses of Tibial Inserts, PS-Post and Additional All Poly Tibia PS-Post implants. Both proposed geometries are fabricated from both Standard Poly and Vitamin E UHMWPE (E-Link).

#### Predicate Devices:

The modified Klassic® System is substantially equivalent to the primary predicate Klassic® Knee System (K112906), and other identified predicates from the Klassic® Knee System (K162422, K183596) with respect to design, materials, function and indications for use.

#### Comparison of Technological Characteristics:

The modified Klassic® Knee System features the same materials (GUR 1050 UHMWPE -"Standard Poly" and Vitamin E UHMWPE = "E-Link"), same use in primary or revision Total Knee Arthroplasty, and same EO sterilization compared to the predicate Klassic® Knee System (K112906, K162422, K183596).

Differences include the addition of an All-Poly Tibia, PS-Post implant as compared to the cleared All-Poly Tibia, Ultra-PS and All-Poly Tibia, CR-Congruent versions (K162422), and three additional thicknesses (18, 21, 24mm) added to the already cleared Tibial Inserts, PS-Post (K183956), which are identical in thickness to those of the cleared Tibial Inserts, PS-Max (K202740).

#### Discussion of Non-Clinical Testing/Performance Data:

Testing and engineering analyses were performed to evaluate the subject components. Additionally, the Klassic® Revision System is in compliance with LAL testing requirements for orthopedic implants.

Non-clinical testing and engineering analysis conducted to demonstrate substantial equivalence was as follows:

- Femoral/Tibial Constraint Testing (ASTM F1223)
- Contact Area/Contact Stress (ASTM F2083) ●
- Post Fatigue Testing ●
- Range of Motion Evaluation
- Wear (ISO 14243-3)
- Tibial Insert Modular Disassembly Strength (ASTM F1814) ●

#### Conclusion:

Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities, demonstrating that the subject components perform as safe and effective compared to the predicate components, and is substantially equivalent to the predicate.