Who is the manufacturer of Delta TT Pro?

Lima Corporate S.P.A. filed the 510(k) submission for Delta TT Pro (K182099).

What is the FDA product code for Delta TT Pro?

LPH. It is classified under 21 CFR 888.3358 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Delta TT Pro?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Delta TT Pro?

Delta TT Acetabular System (K112898, K141395); G7 Acetabular System (K140669).

Who can help prepare an FDA 510(k) submission like Delta TT Pro?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Delta TT Pro

K182099 · Lima Corporate S.P.A. · LPH · Dec 26, 2018 · Orthopedic

Device Facts

Record ID	K182099
Device Name	Delta TT Pro
Applicant	Lima Corporate S.P.A.
Product Code	LPH · Orthopedic
Decision Date	Dec 26, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Delta 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 Acetabular System is intended for cementless use.

Device Story

Delta TT Pro is a cementless acetabular system for total hip arthroplasty. System comprises Ti6Al4V acetabular cup and Vitamin E-stabilized cross-linked UHMWPE (LimaVit) liners; available in neutral, protruded, and high-wall designs. Liners articulate with Biolox Delta or CoCrMo femoral heads coupled to femoral stems. Bone screws provide supplemental cup stability. Used in hospital/clinical settings by orthopedic surgeons. Device replaces diseased/damaged hip joint components to reduce pain and improve function. Substantial equivalence established via bench testing (push-out, lever-out, torque-out, stiffness, impingement, and wear tests).

Clinical Evidence

Bench testing only. Performed mechanical verification and validation including push-out, lever-out, torque-out, stiffness, impingement, and wear testing to confirm product specifications and safety/effectiveness equivalence.

Technological Characteristics

Materials: Ti6Al4V (acetabular cup), Vitamin E-stabilized cross-linked UHMWPE (liners). Design: Cementless, semi-constrained, porous-coated. Configurations: Neutral, protruded, high-wall. Fixation: Uncemented, optional bone screws. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring total hip arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, hip dysplasia), rheumatoid arthritis, post-traumatic arthritis, functional deformity, hip fractures/dislocation, failed cup arthroplasty, or revisions with adequate 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

Delta TT Acetabular System (K112898, K141395)
G7 Acetabular System (K140669)

Related Devices

K200656 — Delta Multihole TT Pro Acetabular System · Lima Corporate S.P.A. · Jul 8, 2020
K141395 — DELTA TT ACETABULAR SYSTEM · Lima Corporate S.P.A. · Jun 30, 2014
K112898 — DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS · Lima Corporate S.P.A. · Dec 21, 2012
K103721 — MPACT ACETABULAR SYSTEM · Medacta International · Mar 21, 2011
K100269 — NOVATION CROWN CUP GXL LINERS · Exactech, Inc. · May 27, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ December 26, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Limacorporate S.p.A. Roberto Gabetta Regulatory Manager via Nazionale 52 Villanova di San Daniele, 33038 It # Re: K182099 Trade/Device Name: Delta TT Pro 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: November 23, 2018 Received: November 30, 2018 # Dear Roberto Gabetta: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel S. Ramsey -S 2018.12.26 15:34:29 -05'00' FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K182099 Device Name Delta TT Pro ## Indications for Use (Describe) The Delta 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 Acetabular System is intended for cementless use. | Type of Use (Select one or both, as applicable) | <input type="checkbox"/> | |-------------------------------------------------|--------------------------| |-------------------------------------------------|--------------------------| |X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Lima Corporate. The logo consists of a red abstract symbol on the left, followed by the words "Lima" in bold black letters and "Corporate" in light gray letters. Below "Lima Corporate" is the text "Orthopaedic" in light gray, followed by a red diamond shape and the word "motion" in black. Section 7 - 510(k) Summary (in accordance with 21 CFR 807.92) 510(k) Number K ### I. Applicant Information | Applicant: | Limacorporate S.p.A. | |----------------------------|--------------------------------------------------------------------------------------------------| | | Via Nazionale, 52 | | | Villanova di San Daniele | | | Udine 33038 | | | Italy | | Contact Person: | Roberto Gabetta | | | Regulatory Affairs Manager | | | Tel: +39 0432945511 | | | Fax: +39 0432945512 | | | e-mail: <a href="mailto:roberto.gabetta@limacorporate.com">roberto.gabetta@limacorporate.com</a> | | Application Correspondent: | Same as Applicant. | Date Prepared: August 3, 2018 ### II. Device Identification | Proprietary Name: | Delta TT Pro | |-----------------------|------------------------------------------------| | Common/Usual Name: | Total Hip Prosthesis | | Classification Name: | Hip joint metal/polymer/metal semi-constrained | | | porous-coated uncemented prosthesis | | Regulation Number: | 21 CFR 888.3358 | | Product Codes: | LPH, MBL | | Classification: | Class II | | Classification Panel: | Orthopedic Devices | ### III. Predicate Devices The Delta TT Pro device is substantially equivalent to the following FDA cleared predicate devices with regard to indications for use, performance and technological characteristics: 510(k) Number: K112898, K141395 {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for LimaCorporate. The logo consists of a red symbol on the left, followed by the word "Lima" in black and the word "Corporate" in gray. Below the word "Corporate" is the phrase "Orthopaedic motion" in gray, with the word "motion" in red. | Trade Name: | Delta TT Acetabular System | |----------------------|------------------------------------------------------------------------------------| | Manufacturer: | Limacorporate S.p.A. | | Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis | | Common/Usual Name: | Total Hip Prosthesis | | Regulation Number: | 21 CFR 888.3358 | | Product Code: | LPH, MBL, JDI, LZO | | Classification: | Class II | | 510(k) Number: | K140669 | | Trade Name: | G7 Acetabular System | | Manufacturer: | Biomet Manufacturing Corp. | | Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis | | Common/Usual Name: | Total Hip Prosthesis | | Regulation Number: | 21 CFR 888.3358 | | Product Code: | LPH, LZO, OQG, KWZ, JDI, OQH, OQI, PBI | | Classification: | Class II | ### IV. Device Description The Delta TT Pro is an acetabular system, intended for total hip replacement in cementless applications. The system consists of a Delta TT Pro acetabular cup (Ti6Al4V) and LimaVit liners (cross-linked UHMWPE with Vitamin E), available in three different design: neutral, protruded and high-wall. The LimaVit liners articulate with the Biolox®Delta and CoCrMo femoral heads, which are coupled to LimaCorporate femoral stems. Bone screws may be used to give further stability to the cup. ### Indications for Use Statement V. The Delta 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 Acetabular System is intended for cementless use. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Lima Corporate Orthopaedic. The logo features a red abstract symbol resembling a person in motion, followed by the words "Lima" in bold black and "Corporate" in gray. Below "Lima Corporate" is the word "Orthopaedic" in gray, followed by a red diamond shape and the word "motion" in black. ### VI. Summary of the Technical Characteristics The intended use, design, and materials of the Delta TT Pro are substantially equivalent to the intended use, design, and materials of the predicate devices. All required design control activities have been completed and the results indicated that the subject device is substantially equivalent to the predicate devices, in terms of safety and effectiveness. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Lima Corporate Orthopaedic Motion. The words "Lima Corporate" are stacked vertically in a bold, sans-serif font. To the right of "Corporate" are the words "Orthopaedic" and "motion" stacked on top of each other in a smaller font. A red symbol is located below the word "Lima". # Predicate Device Comparison Table | Device Name | Subject Device: Delta TT Pro | Predicate Device: (K112898,K141395) Delta TT Acetabular System | Predicate Device: (K140669) G7 Acetabular System (OsseoTi acetabular shell with El acetabular liner) | Significant Differences | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LPH, MBL | LPH, MBL, JDI, LZO | LPH, LZO, OQG, KWZ, JDI, OQH, OQI, PBI | No significant differences. The subject device is classified as Product Code LPH and MBL under regulation 888.3358, whereas the predicate devices are classified under regulation 888.3358 with Product Codes LPH, MBL, JDI, LZO (Delta TT) and LPH, LZO, OQG, KWZ, JDI, OQH, OQI, PBI (G7 Acetabular System). However, the three products present substantially equivalent features as well as substantially equivalent safety and effectiveness characteristics. | | Regulation # | 888.3358 | 888.3358 | 888.3358 | | | Class | II | II | II | No difference. | | Device Name | | | Significant Differences | | | | Subject Device: Delta TT Pro | Predicate Device: (K112898,K141395) Delta TT Acetabular System | Predicate Device: (K140669) G7 Acetabular System (OsseoTi acetabular shell with E1 acetabular liner) | | | Indications for Use | • 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. Intended for cementless use. | • 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. Intended for cementless use. | • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. • Rheumatoid arthritis. • Correction of functional deformity. • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. • Revision of previously failed total hip arthroplasty. Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non coated or polyethylene | No significant differences. The subject and predicate devices have essentially identical Indications for Use, with the minor exception that the G7 Acetabular System is also indicated in cases of non- union and trochanteric fractures (see parts in yellow). | | | Subject Device: | Predicate Device: (K112898,K141395) | Predicate Device: (K140669) | Significant Differences | | Device Name | Delta TT Pro | Delta TT Acetabular System | G7 Acetabular System (OsseoTi acetabular shell with E1 acetabular liner) | | | | | | mating components that are indicated for either cemented or uncemented use. | | | Environment of Use | Clinical/Hospital Environment. | Clinical/Hospital Environment. | Clinical/Hospital Environment. | No difference. | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Lima Corporate. The text "Lima Corporate" is stacked vertically in black font. To the right of "Corporate" is the text "Orthopaedic motion" in a smaller, gray font, with a red arrow pointing to the left. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Lima Corporate Orthopaedic Motion. The logo is vertically oriented, with the Lima Corporate text stacked on top of each other. Below the text is a red symbol, and to the right of the text is the word Orthopaedic and the word motion with a red symbol. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Lima Corporate. The logo consists of a red abstract symbol resembling a person with outstretched arms, followed by the words "Lima" in black and "Corporate" in gray. Below "Lima Corporate" is the word "Orthopaedic" in gray, followed by a red symbol and the word "motion" in gray. ### VII. Summary of Performance Data Limacorporate has conducted extensive verification and validation testing of the Delta TT Pro as a Hip Prosthesis intended for use in total hip arthroplasty. All verification and validation testing confirms that the product specifications are met, in support of the substantial equivalence of the intended use and technological characteristic as the predicate devices. The Delta TT Pro has been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate according to its intended use and in a manner substantially equivalent to the predicate devices. The main groups of tests performed include: - Push out, lever out and torque out disassembly test - . Stiffness test - Impingement test ● - o Wear test ### Substantial Equivalence Conclusions VIII. Based on the comparison of intended use, principles of operation and technological characteristics, the Delta TT Pro device is deemed to be substantially equivalent to the Delta TT Acetabular System, manufactured by Limacorporate S.p.A. (K112898, K141395) and the G7 Acetabular System, manufactured by Biomet Manufacturing Corp. (K140669). The minor differences identified between the Delta TT Pro and its predicate devices raise no new issues of safety or effectiveness. The performance and validation data demonstrate that the Delta TT Pro is as safe and effective as the predicate devices.