Who is the manufacturer of iTotal® Hip Replacement System?

Conformis, Inc. filed the 510(k) submission for iTotal® Hip Replacement System (K162719).

What is the FDA product code for iTotal® Hip Replacement System?

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

What is the regulatory pathway for iTotal® Hip Replacement System?

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

What are the predicate devices for iTotal® Hip Replacement System?

Pipeline Total Hip System (K112802); Corail AMT Hip Prosthesis (K042992); Signature Planner, Signature Guides (K111863).

Who can help prepare an FDA 510(k) submission like iTotal® Hip Replacement System?

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.

iTotal® Hip Replacement System

K162719 · Conformis, Inc. · LPH · Jun 14, 2017 · Orthopedic

Device Facts

Record ID	K162719
Device Name	iTotal® Hip Replacement System
Applicant	Conformis, Inc.
Product Code	LPH · Orthopedic
Decision Date	Jun 14, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3358
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to: · A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis. or congenital hip dysplasia. · Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. · Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation. The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach.

Device Story

Patient-specific hip replacement system; utilizes pre-operative CT scans to design custom femoral neck and acetabular components; includes standard femoral stems, femoral heads, and polyethylene liners. System includes patient-specific instrumentation (iJigs) for intra-operative positioning and bone cutting/reaming. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Design process involves proprietary software to translate patient anatomy into custom implant geometry. Benefits include patient-specific fit for cementless fixation. Output is a set of implants and guides tailored to patient anatomy, facilitating surgical execution and potentially improving joint function.

Clinical Evidence

Bench testing only. Testing included femoral stem/neck fatigue, taper junction testing, acetabular liner-cup disassembly, impingement, wear testing (adhesive/abrasive), HA coating characterization (microstructure, bonding, shear fatigue), range of motion, iJig drop/resection simulation, iPoly XE characterization, and cadaveric evaluation. Software verification and validation were also performed.

Technological Characteristics

Materials: Titanium alloy, Cobalt Chromium alloy, Vitamin E infused highly cross-linked UHMWPE (iPoly® XE), hydroxyapatite (HA) coating. Design: Semi-constrained, cementless, patient-specific femoral neck and acetabular cup. Sterilization: Sterile (SAL 10^-6), single-use. Connectivity: Proprietary software for design based on CT imaging.

Indications for Use

Indicated for skeletally mature individuals requiring total hip replacement due to osteoarthritis, traumatic/rheumatoid arthritis, avascular necrosis, congenital hip dysplasia, non-displaced non-unions, femoral neck fractures, trochanteric fractures with head involvement, or revision of failed previous hip surgery (excluding hardware presence).

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

Pipeline Total Hip System (K112802)
Corail AMT Hip Prosthesis (K042992)
Signature Planner, Signature Guides (K111863)

Reference Devices

iTotal® CR & PS Knee Replacement Systems (K160025 & K161668)

Related Devices

K231178 — ACTERA hip system · Conformis, Inc. · May 23, 2023
K192198 — Conformis Hip System · Conformis, Inc. · Nov 6, 2019
K223348 — My3D® Personalized Pelvic Reconstruction · Onkos Surgical, Inc. · Jan 30, 2023
K161668 — ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) · Conformis, Inc. · Jul 15, 2016
K212815 — My3D® Personalized Pelvic Reconstruction · Onkos Surgical · Jul 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 14, 2017 ConforMIS, Inc. Emmanuel Nyakako Sr. Vice President, Regulatory And Quality Affairs 600 Technology Park Drive Billerica, MA 01821 Re: K162719 Trade/Device Name: iTotal® Hip Replacement 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, LZO, MEH, OQG Dated: May 15, 2017 Received: May 16, 2017 Dear Mr. Nyakako: 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K162719 Device Name iTotal® Hip Replacement System #### Indications for Use (Describe) The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to: · A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis. or congenital hip dysplasia. · Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. · Revision procedures for failed previous hip surgery (excluding situations where hardware is present). The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation. The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach. | 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) | #### 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}------------------------------------------------ ### 6.0 510(K) SUMMARY (PAGE 1 OF 5) | Submitter's Name and Address: | ConforMIS, Inc. 600 Technology Park Drive Billerica, MA 01821 | |---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 3009844603 and 3004153240 | | Date of Summary: | June 9, 2017 | | Contact Person: | Emmanuel O. Nyakako, Sr. Vice President, Regulatory and Quality Affairs | | Telephone Number: Fax Number: | (781) 345-9164 (781) 345-0147 | | Name of the Device: | iTotal® Hip Replacement System | | Common Name: | Total Hip Replacement System | | Regulatory Status and Regulation Number: Classification Name: | Class II 21 CFR 888.3358 21 CFR 888.3353 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis and Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | | Device Classification: | Product Code: LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented | | | LZO: Hip joint metal/ceramic/polymer semi constrained cemented or nonporous uncemented | | | MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium phosphate | | | OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented | {4}------------------------------------------------ #### 510(K) SUMMARY (PAGE 2 OF 5) | Indications for Use: | The iTotal® Hip Replacement System is designed from a patient's pre-operative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. Total hip replacement using the iTotal® Hip Replacement System is indicated for use in skeletally mature individuals undergoing total hip replacement due to: • A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia. • Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. • Revision procedures for failed previous hip surgery (excluding situations where hardware is present). | | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | | The iTotal® Hip Replacement System includes standard hip replacement components as well as the following patient specific components: femoral neck, acetabular cup, single use instrumentation. | | | | The iTotal® Hip Replacement implants are intended for cementless fixation using an anterior or posterior surgical approach. | | | Identification of the Legally Marketed Devices (Predicate Devices): | Pipeline Total Hip System Device Class: Product Code: Regulation Number: 510(k) Number: | II LPH, JDI, OQG, OQH 21 CFR 888.3358 K112802 | | | Corail AMT Hip Prosthesis Device Class: Product Code: Regulation Number: 510(k) Number: | II LZO 21 CFR 888.3353 K042992 | | | Signature Planner, Signature Guides Device Class: Product Code: Regulation Number: 510(k) Number: | II LPH, LZO, KWZ, JDI, KWY, MAY MEH 21 CFR 888.3358 K111863 | | Identification of the Legally Marketed Devices (Reference Devices): | iTotal® CR & PS Knee Replacement Systems Device Class: Product Code: Regulation Number: 510(k) Number: | II JWH, OOG, OIY 21 CFR 888.3560 K160025 & K161668 | {5}------------------------------------------------ #### 510(K) SUMMARY (PAGE 3 OF 5) | 510(K) SUMMARY (PAGE 3 OF 5) | | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description: | The iTotal® Hip Replacement System is a patient specific hip replacement system which consists of femoral and acetabular components and patient specific instrumentation (iJigs). The femoral component consists of a standard femoral stem body with an integrated (non-modular) patient specific neck, which connects with a standard femoral head. The acetabular component consists of a metal acetabular cup with two screw holes and polyethylene liners in standard sizes. Standard bone screws and apex hole plug may also be provided with the iTotal® Hip Replacement System. | | | The iTotal® Hip Replacement System is intended to treat skeletally mature patients who are candidates for total hip replacement surgery. | | | Using patient imaging (CT scan) and a combination of proprietary and off the shelf software, a patient specific hip replacement system is designed. The iTotal® Hip Replacement System consists of the following components: a) Femoral Component: The femoral stem, with an integrated patient specific neck, is manufactured from titanium alloy and has a plasma sprayed hydroxyapatite (HA) coating. The femoral stem is available in various sizes. Both metal (Cobalt Chromium alloy) and Ceramic femoral heads are available for use with the iTotal® Hip Replacement System. The femoral heads are available in various sizes and offsets. | | | b) Acetabular Component: The acetabular cup is manufactured from titanium alloy. The acetabular cup features a plasma sprayed outer surface. The acetabular cups are available in various sizes. The acetabular liner is manufactured from highly cross- linked Vitamin E infused ultra-high molecular weight polyethylene (iPoly® XE). The liners are available in a range of sizes with varying internal diameters and offsets. Acetabular screws and the apex hole plug are manufactured from titanium alloy. | | | c) Ancillary orthopedic manual surgical instruments are provided with the iTotal® Hip Replacement system to assist with implantation. The ancillary instruments are provided sterile and for single-use only. These patient specific instruments are provided to assist in the positioning of total hip replacement components intra-operatively and in guiding the cutting/reaming of bone. | {6}------------------------------------------------ ## 510(K) SUMMARY (PAGE 4 OF 5) | Summary of Technological Characteristics: | The rationale for substantial equivalence is based on consideration of the following device use and characteristics: | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • | Intended Use: Similar to the predicate devices, the proposed iTotal® Hip Replacement System is intended to be as a total hip prosthesis. | | | • | Indications for Use: The proposed indications for use for the iTotal® Hip Replacement System are similar to the predicate devices as they have the same intended use. | | | • | Operating Principle/Fundamental Technology: Similar to the predicate devices the proposed iTotal® Hip Replacement System is a semi-constrained, cementless artificial hip replacement system; it consists of a femoral stem with an integrated neck and a standard femoral head, an acetabular cup with polyethylene liner, with optional acetabular screws/apex holes plug, and ancillary instrumentation. | | | • | Materials/Coatings: The proposed iTotal® Hip Replacement system uses the same biocompatible materials (i.e. titanium alloy) and coatings (i.e. hydroxyapatite) as the predicate devices | | | • | Sterilization: Similar to the predicates, the proposed iTotal® Hip is intended to be provided sterile (SAL 1.0x10-6) and for single use. | {7}------------------------------------------------ ### 510(K) SUMMARY (PAGE 5 OF 5) | Substantial Equivalence: | The iTotal® Hip Replacement System, subject of this premarket notification is substantially equivalent to the Pipeline Total Hip System (K112802, cleared March 09, 2012), the Corail AMT Hip Prosthesis (K042992, cleared February 11, 2005), and the Signature Planner and Signature Guides (K111863, cleared June 11, 2012). Non-clinical testing was conducted in accordance with applicable FDA guidance documents to confirm that the iTotal® Hip Replacement System is substantially equivalent to the predicate hip systems. Specifically, the following testing was performed to establish substantial equivalence: Femoral Stem Fatigue Testing Femoral Neck Fatigue Testing Femoral Taper-CoCr head Junction Testing Femoral Taper-Ceramic Head Junction Testing Acetabular Liner-Cup Disassembly Testing Acetabular Liner Impingement Testing Wear Testing: Adhesive and Abrasive Wear Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Bonding Strength (Tensile and Static Fatigue) Testing HA Coating Shear Fatigue Testing Range of Motion Testing iJig Drop Testing iJig Femoral Neck Resection Simulation Characterization of iPoly XE Cadaveric Evaluation Software Verification/Validation Bacterial Endotoxin Testing All testing has demonstrated that the device is substantially equivalent to the predicate devices. | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion: | Based on the testing conducted, it is concluded that the iTotal® Hip Replacement System is substantially equivalent to the predicate devices: The Pipeline Total Hip System (K112802, cleared March 09, 2012), Corail AMT Hip Prosthesis (K042992, cleared February 11, 2005), and Signature Planner, Signature Guides (K111863, cleared June 15, 2012). |