(145 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and performance of a hip prosthesis, with no mention of AI or ML technologies.
Yes
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in patients with various conditions, which directly addresses a medical condition and aims to improve a patient's health.
No
This device is a total hip arthroplasty system, which is a medical implant used for treatment, not for diagnosing a condition. Its purpose is to replace parts of the hip joint to relieve pain and improve function.
No
The device description clearly states it is an acetabular system consisting of physical components (cup, liners, screws) intended for surgical implantation, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Delta Acetabular System is for use in total hip arthroplasty to address conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is described as an acetabular system consisting of a cup, liners, and components that articulate with femoral heads. These are physical implants designed to replace a joint, not reagents or instruments used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, or tissue), to diagnose a condition based on such testing, or to provide information about a patient's health status through in vitro analysis.
In summary, the Delta Acetabular System is a surgical implant used in total hip replacement, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Clinical/Hospital Environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
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) | |
|---|---|
| ------------------------------------------------- | -------------------------- |
|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: roberto.gabetta@limacorporate.com | |
| 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.