ATTUNE All-Polyethylene Tibia

K193057 · Depuy Ireland UC · JWH · Jan 30, 2020 · Orthopedic

Device Facts

• Record ID: K193057
• Device Name: ATTUNE All-Polyethylene Tibia
• Applicant: Depuy Ireland UC
• Product Code: JWH · Orthopedic
• Decision Date: Jan 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cemented Total Knee Arthroplasty

Device Story

The ATTUNE All Polyethylene Tibia is a monobloc tibial component used in total knee arthroplasty. It is manufactured from AOX polyethylene and is designed to be used in a cemented fixation. The device is intended to mate with existing ATTUNE cemented and cementless femoral components and existing ATTUNE patella components. It is used by orthopedic surgeons in a clinical setting to replace a damaged or diseased knee joint. By providing a stable, articulating surface, the device aims to restore joint function and reduce pain for the patient. The device is provided sterile and is intended for single use.

Clinical Evidence

No clinical testing was conducted to demonstrate substantial equivalence. Evidence is based on non-clinical bench testing, including contact area/pressure, wear, constraint on the tibiofemoral interface, spine fatigue, fixation testing, and range of motion analysis, alongside bacterial endotoxin testing per ANSI AAMI ST-72-2011.

Technological Characteristics

Material: AOX UHMWPE. Fixation: Cemented. Design: Monobloc all-polyethylene tibial component. Sizes: CR and PS configurations, sizes 1-10. Sterilization: Gamma radiation (75-90 kGy). Packaging: Foil/LLDPE/Polyester pouch in Tyvek/blister tray. Shelf life: 5 years. No software or electronic components.

Indications for Use

Indicated for patients with severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

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

• Darwin Knee System (K943462)
• Darwin Knee System (Cruciate-Substituting) Porous Coated and Non-Porous Coated (K950010)
• P.F.C. Cruciate Retaining Knee System (Size 1.5) (K961685)
• P.F.C. Sigma Knee System (Size 1.5) (K971189)
• DePuy ATTUNE Knee System (K101433)

Submission Summary (Full Text)

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January 30, 2020

DePuy Ireland UC % Kellie Myers Senior Regulatory Affairs Specialist DePuy Synthes, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K193057

Trade/Device Name: ATTUNE All Polyethylene Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: October 31, 2019 Received: November 1, 2019

Dear Kellie Myers:

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,

Ting Song Acting 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) K193057

Device Name

ATTUNE All Polyethylene Tibia

#### Indications for Use (Describe)

Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div style="display:flex; align-items:center;"> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 510(K) SUMMARY

(As required by 21 CFR 807.92 and 21 CFR 807.93)

| Submitter Information | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | DePuy Ireland UC |
| Address | Loughbeg, Ringaskiddy<br>Co. Cork Munster, IRELAND |
| Phone number | 574-372-7276 |
| Fax number | 574- 371-4987 |
| Establishment Registration<br>Number | 3015516266 |
| Name of contact person | Kellie Myers |
| Date prepared | 27 September 2019 |
| Name of device | |
| Trade or proprietary name | ATTUNE All Polyethylene Tibia |
| Common or usual name | Total Knee Arthoplasty Prosthesis |
| Classification name | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained<br>cemented prosthesis |
| Class | II |
| Classification panel | 87 Orthopedics |
| Regulation | 21 CFR 888.3560 |
| Product Code(s) | JWH |
| Legally marketed device(s) to<br>which equivalence is claimed | Darwin Knee System, K943462<br>Darwin Knee System (Cruciate-Substituting) Porous Coated and Non-<br>Porous Coated, K950010<br>P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685<br>P.F.C. Sigma Knee System (Size 1.5), K971189<br>DePuy ATTUNE Knee System, K101433 |
| Reason for 510(k) submission | This 510(k) submission is to add the ATTUNE All Polyethylene Tibia to the<br>currently cleared ATTUNE Knee System. |
| Device description | The subject device is an all polyethylene tibia component made from AOX<br>Polyethylene that mates with existing ATTUNE cemented (K101433) and<br>cementless (K140881) femoral components, and existing ATTUNE patella<br>components (K103756). |
| Intended use of the device | Cemented Total Knee Arthroplasty |
| Indications for use | Candidates for total knee replacement include patients with a severely painful<br>and/or severely disabled joint resulting from osteoarthritis, post-traumatic<br>arthritis, rheumatoid arthritis, or a failed previous implant. |

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| Characteristics | Subject Device:<br>DePuy Synthes<br>ATTUNE All Poly<br>Tibia | Predicate Device #1:<br>Darwin Knee<br>System<br>(K943462) | Predicate Device #2:<br>Darwin Knee System<br>(Cruciate-Substituting)<br>Porous Coated and<br>Non-Porous Coated<br>(K950010) | Predicate Device #3:<br>P.F.C. Cruciate<br>Retaining Knee System<br>(Size 1.5)<br>(K961685) | Predicate Device #4:<br>P.F.C. Sigma Knee<br>System (Size 1.5)<br>(K971189) | Predicate Device<br>#5: ATTUNE<br>Knee System<br>(K101433) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Total knee<br>arthroplasty | Total knee<br>arthroplasty | Total knee arthroplasty | Total knee arthroplasty | Total knee<br>arthroplasty | Total knee<br>arthroplasty |
| Properties<br>Material | AOX UHMWPE | UHMWPE | UHMWPE | UHMWPE | UHMWPE | AOX UHMWPE |
| Fixation | Cemented | Cemented | Cemented | Cemented | Cemented | Cemented |
| Sizes | Cruciate-Retaining<br>(CR)<br>• Sizes 1-10 with<br>5, 6, 7, 8, 9, 10 and<br>12mm options for<br>each<br><br>Posterior-Stabilized<br>(PS)<br>• Size 1-10 with<br>5, 6, 7, 8, 9, 10 and<br>12mm options for<br>each | Curved (CR)<br>• Sizes 2, 2.5, 3, 4,<br>and 5 with 8mm,<br>10mm, 12.5 mm,<br>and 15mm options<br>for each | Stabilized (PS)<br>Sizes 2, 2.5, 3, 4, and 5<br>with 8mm, 10mm, 12.5<br>mm, and 15mm options<br>for each | Curved (CR)<br>Size 1.5 with 8mm,<br>10mm, 12.5 mm, and<br>15mm options | Stabilized (PS)<br>Size 1.5 with 8mm,<br>10mm, 12.5 mm,<br>and 15mm options | CR Fixed Bearing<br>Tibial Inserts<br>• Sizes 1-10 with<br>5, 6, 7, 8, 10, 12,<br>14, 16mm<br>options for each<br><br>PS Fixed Bearing<br>Tibial Inserts<br>• Sizes 1-10 with<br>5, 6, 7, 8, 10, 12,<br>14, 16 mm<br>options for each |
| Design Features<br>Cruciate<br>Retaining (CR)<br>Tibia | Posterior cut-out | Posterior cut-out | N/A | Posterior cut-out | N/A | Posterior cut-out |
| Posterior<br>Stabilized (PS)<br>Tibia | Posterior spine | N/A | Posterior spine | N/A | Posterior spine | Posterior spine |

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| Modularity | Packaging | Sterile Method | Sterility<br>Assurance Level | Shelf Life | Packaging<br>Description | Compatible<br>CR Tibial<br>Component |
|----------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Monobloc tibial<br>component made of<br>all polyethylene | | Gamma radiation<br>(75kGy to 90 kGy)<br>(50-60 kGy<br>crosslinking dose,<br>then 25-40 kGy<br>terminal sterilization<br>dose) | 10-6 | 5 years | Inner foil pouch<br>laminated out of<br>foil/LLDPE/Polyester<br>materials and<br>vacuumed, packaged<br>inside a Tyvek/blister<br>tray with a foam<br>protector<br>configuration | ATTUNE CR<br>Femoral Components<br>(porous coating (PC)<br>or no PC) |
| Monobloc tibial<br>component made of<br>all polyethylene | | Gamma radiation<br>(25kGy to 50 kGy<br>single dose) | 10-6 | 5 years | Inner foil pouch<br>laminated out of<br>foil/LLDPE/Polyester<br>materials and<br>vacuumed, packaged<br>inside a Tyvek/blister<br>tray with a foam<br>protector<br>configuration | P.F.C. II CR Femoral<br>Component (PC or<br>no PC) |
| Monobloc tibial<br>component made of<br>all polyethylene | | Gamma radiation<br>(25kGy to 50 kGy<br>single dose) | 10-6 | 5 years | Inner foil pouch<br>laminated out of<br>foil/LLDPE/Polyester<br>materials and<br>vacuumed, packaged<br>inside a Tyvek/blister<br>tray with a foam<br>protector<br>configuration | P.F.C. II CS Femoral<br>Component (PC or no<br>PC) |
| Monobloc tibial<br>component made of<br>all polyethylene | | Gamma radiation<br>(25kGy to 50 kGy<br>single dose) | 10-6 | 5 years | Inner foil pouch<br>laminated out of<br>foil/LLDPE/Polyester<br>materials and<br>vacuumed, packaged<br>inside a Tyvek/blister<br>tray with a foam<br>protector<br>configuration | P.F.C. II CR Femoral<br>Component (PC or no<br>PC) |
| Monobloc tibial<br>component made of<br>all polyethylene | | Gamma radiation<br>(25kGy to 50 kGy<br>single dose) | 10-6 | 5 years | Inner foil pouch<br>laminated out of<br>foil/LLDPE/Polyester<br>materials and<br>vacuumed, packaged<br>inside a Tyvek/blister<br>tray with a foam<br>protector<br>configuration | P.F.C. II CS Femoral<br>Component (PC or no<br>PC) |
| Tibial inserts snap<br>into modular tibial<br>trays | | Gamma radiation<br>(75kGy to 90 kGy<br>single dose) | 10-6 | 5 years | Inner foil pouches<br>and outer rigid<br>blister trays with<br>Tyvek lids | ATTUNE CR<br>Femoral<br>Component (PC or<br>no PC)<br>ATTUNE Fixed<br>Bearing Tibial<br>Baseplates |

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| PS Tibial<br>Component | ATTUNE Medialized<br>Dome Patella;<br>ATTUNE Medialized<br>Anatomic Patella | P.F.C. II System<br>Oval-Dome Patella | P.F.C. II CR Femoral<br>Component (PC or<br>no PC) | P.F.C. II CS Femoral<br>Component (PC or no<br>PC) | P.F.C. II System<br>Oval-Dome Patella | ATTUNE<br>Medialized Dome<br>Patella; ATTUNE<br>Medialized<br>Anatomic Patella |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------------------------|----------------------------------------------------|----------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------|
| | ATTUNE PS<br>Femoral Components<br>(PC or no PC) | P.F.C. II System Oval-<br>Dome Patella | P.F.C. II CR Femoral<br>Component (PC or<br>no PC) | P.F.C. II CS Femoral<br>Component (PC or no<br>PC) | P.F.C. II System<br>Oval-Dome Patella | ATTUNE PS<br>Femoral<br>Components (PC or<br>no PC) |
| | ATTUNE Medialized<br>Dome Patella;<br>ATTUNE Medialized<br>Anatomic Patella | P.F.C. II System Oval-<br>Dome Patella | P.F.C. II System Oval-<br>Dome Patella | P.F.C. II System<br>Oval-Dome Patella | P.F.C. II System<br>Oval-Dome Patella | ATTUNE Fixed<br>Bearing Tibial<br>Baseplates |
| | | | | | | ATTUNE<br>Medialized Dome<br>Patella; ATTUNE<br>Medialized<br>Anatomic Patella |
| PERFORMANCE DATA | | | | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | | | | |
| The following tests were performed (per FDA's Class II Special Controls Guidance Document: Knee Joint Patellofemerotibial and Femerotibial<br>Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA) on the ATTUNE All Polyethylene Tibia to demonstrate<br>substantial equivalence of safety and efficacy with the predicate device: | | | | | | |
| Contact Area / Pressure (PS and CR)Wear (PS and CR)Constraint on tibiofemoral interface (PS and CR)Spine Fatigue (PS)C2 Fixation Testing (PS)Range of Motion (PS and CR) | | | | | | |
| The proposed devices also meet the requirement of bacterial endotoxin testing as specified in ANSI AAMI ST-72-2011 | | | | | | |

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| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL | INFORMATION |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| No clinical testing was conducted to demonstrate substantial equivalence. | |
| | CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
| | The subject DePuy Synthes ATTUNE All Polyethylene Tibia is substantially equivalent to the predicate Sigma All Polyethylene Tibia cleared under |

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