DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS

K112898 · Lima Corporate S.P.A. · LPH · Dec 21, 2012 · Orthopedic

Device Facts

• Record ID: K112898
• Device Name: DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
• Applicant: Lima Corporate S.P.A.
• Product Code: LPH · Orthopedic
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; - Rheumatoid arthritis; - Post-traumatic arthritis, - Correction of functional deformity; - Fractures, dislocation of the hip and unsuccessful cup arthroplasty; - Revisions in cases of good remaining bone stock. The Delta TT cup is intended for cementless use.

Device Story

Delta TT Acetabular System is a cementless hip prosthesis; consists of a titanium alloy (Ti6Al4V) cup with a Trabecular Titanium external structure, a UHMWPE liner, and a modular metal femoral head. The cup is manufactured via Electron Beam Melting (EBM). The system is used in total hip arthroplasty procedures performed by orthopedic surgeons in a hospital/surgical setting. The cup features a hemispherical shape with a polar threaded hole for insertion and lateral holes for optional bone screw fixation. Liners (neutral or protruded) couple to the cup via a taper mechanism with a peripheral ring and polar peg for rotational and lever-out stability. The device replaces the natural acetabulum to restore hip function and reduce pain. Clinical benefit is derived from biological fixation of the porous titanium structure to bone and the articulation of the femoral head within the polyethylene liner.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing only, including mechanical testing (deformation, fatigue, push-out, lever-out, torque-out), wear simulation, range of motion simulation, and biocompatibility testing. Material properties of EBM-manufactured Ti6Al4V were characterized and compared to standard materials used in predicate devices.

Technological Characteristics

Materials: Ti6Al4V (ASTM F1472/ISO 5832-3) for cups and screws; UHMWPE (ASTM F648/ISO 5834-2) or cross-linked UHMWPE for liners. Manufacturing: Electron Beam Melting (EBM) for porous titanium structure. Design: Hemispherical cup with taper coupling for liners. Fixation: Cementless, porous-coated for biological fixation. Connectivity: None (mechanical implant).

Indications for Use

Indicated for skeletally mature patients undergoing total hip arthroplasty for pain relief or improved function due to osteoarthritis, avascular necrosis, hip dysplasia, rheumatoid arthritis, post-traumatic arthritis, functional deformity, fractures, hip dislocation, failed cup arthroplasty, or revisions with good bone stock.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Continuum and Trilogy Integrated taper Acetabular systems (K091508)
• Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (K070369 / K042051)
• Reflection Dual Dimension shell (K960094)
• Pinnacle Acetabular System (K001534)
• Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell (K102975)
• FMP Cups (K973119, K974093, K974095, K072154)
• CLS Spotorno Expansion Cup / Threaded Acetabular Cup (K850766)
• Zimmer Trabecular Metal Modular Acetabular System (K021891)
• Trilogy Acetabular System (K953490, K934765)
• Alloclassic Zweymuller Cup (K851213)

Submission Summary (Full Text)

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# DEC 2 1 2012

# Summary of Safety and Effectiveness

Date: May 22, 2012

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: [phone]

| Product | Product Code | Regulation and Classification Name |
|-------------------------------|--------------|--------------------------------------------------------------------------------------------------------------|
| Delta TT Acetabular<br>System | LPH, MBL | Hip joint metal/polymer/metal semi-constrained<br>porous-coated uncemented prosthesis per 21<br>CFR 888.3358 |

#### Description:

The Delta TT Acetabular System consists of a Delta TT cup, a liner and a modular metal femoral head. Bone screws can also be used to give further stability to the cup.

The Delta TT cup is manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ASTM F1472 - ISO 5832-3). The Delta TT cup consists of a non porous bulk interior surface and a Trabecular Titanium structure on the external surface.

The Delta TT cup has an external hemi-spherical shape. A polar threaded hole is used for introduction of the cup and mates with the polar peg of the liner when the two components are assembled. Three threaded holes in lateral positions allow additional fixation of the cup using bone screws (polyethylene plugs are used when bone screws are not required). The Delta TT cup is designed to be coupled with ultra high molecular weight polyethylene (UHMWPE) liners by means of a taper coupling.

Delta TT cups are available with external diameters of 44, 46 and 48 mm (for Small liners), 50 and 52 mm (for Medium liners) and 54, 56, 58, 60, 62 and 64 mm (for Large liners).

The liners for Delta TT cups are manufactured from standard UHMWPE (ASTM F648 -ISO 5834-2) or from cross-linked UHMWPE (X-Lima).

Liners are coupled with the Delta TT cup by means of a taper coupling. Two features are intended to give stability to the coupling. A peripheral ring manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) surrounds the taper of the liner circumferentially, enhancing the rotational stability of the coupling. A polar peg fits into the of the cup, increasing the lever-out stability of the liner. The top of the peg is resurfaced by a Ti6A14V (ASTM F1472 - ISO 5832-3) plug to avoid direct contact between polyethylene and bone.

Traditional 510(k) - Delta TT Acetabular System

Section 5

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Liners are available in two versions: neutral and protruded. The protruded design provides greater coverage of the femoral head and is intended to reduce the risk of dislocation. For both the designs, the following sizes are available:

- Cross-linked UHMWPE liners: Small (for femoral heads Ø 28 mm), Medium (for . femoral heads Ø 28 and 32 mm) and Large (for femoral heads Ø 28, 32 and 36 mm).
- Standard UHMWPE liners: Small, Medium and Large liners for femoral heads Ø 28 . mm.

Bone screws are manufactured from Ti6A14V (ASTM F1472 - ISO 5832-3) and can be used to provide additional initial stability to the cup. Bone screws have a diameter of 6.5 mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60 mm.

Intended Use/Indications: the Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular . necrosis and hip dysplasia;
- . Rheumatoid arthritis;
- . Post-traumatic arthritis,
- Correction of functional deformity; .
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty; .
- . Revisions in cases of good remaining bone stock.

The Delta TT cup is intended for cementless use.

#### Predicate Devices:

Continuum and Trilogy Integrated taper Acetabular systems (Zimmer Inc., K091508); Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners . (Biomet, K070369 / K042051);

Reflection Dual Dimension shell (Smith & Nephew, K960094);

Pinnacle Acetabular System (DePuy, K001534);

Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell (Exactech, Inc. K102975):

FMP Cups (Encore Orthopedics Inc, K973119, K974093, K974095, K072154);

CLS Spotorno Expansion Cup / Threaded Acetabular Cup (Zimmer Inc., K850766);

Zimmer Trabecular Metal Modular Acetabular System (Zimmer Inc., K021891);

Trilogy Acetabular System (Zimmer Inc., K953490, K934765);

Alloclassic Zweymuller Cup (Allo Pro Corp., K851213).

Comparable Features to Predicate Device(s): the Delta TT Acetabular system is similar to the predicate devices in terms of intended use, indications, design and materials.

The Delta TT Acetabular system and the predicate acetabular cups are indicated for use in total hip arthroplasty and are intended for uncemented use.

Traditional 510(k) - Delta TT Acetabular System

Section 5

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The Delta TT acetabular cup is characterized by an outer hemispherical geometry similar to Zimmer, RingLoc (Biomet) and Pinnacle (DePuy) acetabular cups while the Reflection (Smith & Nephew) cups have a hemispherical shape but are wider in the peripheral region. The purpose of the external porous trabecular titanium structure of the Delta TT cup is the same (to allow biological fixation) as the porous coating of the Trabecular Metal (Zimmer), the Regenerex porous titanium construct (Biomet) and the Reflection (Smith & Nephew) cups. The Pinnacle cups (DePuy) are also externally porous coated. The EBM manufacturing technique of Delta TT cups is the same as the Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell (Exactech, Inc. K102975).

Liners for the Delta TT cups are provided in different designs (neutral and protruded): the same designs are also available for the predicate devices although they are named differently. The coupling between the Delta TT cups and liners is very similar to the Continuum (Zimmer) and Pinnacle (DePuy) systems with a tapered coupling in the peripheral region and a spherical geometry in the polar area.

The components of the Delta TT Acetabular system are manufactured from the same materials as the predicate devices.

Non-Clinical Testing: The Delta TT Acetabular system has undergone bench testing, including deformation, fatigue-fretting of the metal shell and push-out, lever-out and torque-out testing to demonstrate the strength of the cup-liner modular connection. The Delta liners have undergone wear tests. A Range of Motion simulation has been performed to ensure the device design does not overly limit range of motion. The Delta TT cups have undergone two point fatigue testing to failure and were compared with FMP cups tested with the same protocol. The EBM Ti6Al4V has undergone characterization for tensile, yield, elongation and rotating beam fatigue properties and the properties were compared with standard materials used for the manufacturing of predicate acetabular cups. Biocompatibility testing has also been completed. All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the system's ability to perform under expected clinical conditions.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Delta TT Acetabular System to the predicate device(s).

Traditional 510(k) - Delta TT Acetabular System

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

December 21, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Limacorporate S.p.A. % Ms. Cheryl Hastings Principle Consultant Hastings Regulatory LLC P.O. Box 696 Winona Lake, Indiana 46590-696

Re: K112898

Trade/Device Name: Delta TT Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis . . . . Regulatory Class: Class II Product Code: LPH, MBL Dated: December 7, 2012 Received: December 10, 2012

Dear Ms. Hastings:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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### Page 2 - Ms. Cheryl Hastings

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Peter D. Rumm -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Unknown

Device Name: Delta TT Acetabular System

Indications for Use:

## Delta TT Acetabular System Indications for Use

The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular . necrosis and hip dysplasia;
- Rheumatoid arthritis; .
- Post-traumatic arthritis, .
- Correction of functional deformity; .
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty. ●
- Revisions in cases of good remaining bone stock. .

The Delta TT cup is intended for cementless use.

| Prescription Use X |
|-----------------------------|
| (Part 21 CFR 801 Subpart D) |

AND/OR

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

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna Asundi
Division of Orthopedic Devices

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Traditional 510(k) - Delta TT Acetabular System