(223 days)
Not Found
No
The device description focuses solely on the materials, design, and components of a total hip joint prosthesis. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a medical implant (Total Hip System) and is used to replace a defective hip joint, which directly addresses a medical condition (severe hip pain and disability) in order to restore function, making it a therapeutic device.
No
Explanation: This device is a total hip joint prosthesis intended to replace a defective hip joint. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components like stems, acetabular systems, bipolar systems, and femoral heads made of materials like Ti6A14V alloy, CoCrMo, and UHMWPE. This indicates a hardware-based medical device, not a software-only one.
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 MultiFit Total Hip System is a prosthesis designed to replace a defective hip joint in patients with various conditions affecting the hip. This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details the components of a hip replacement system (stems, acetabular system, bipolar system, femoral head) made from materials like Ti6A14V, CoCrMo, and UHMWPE. These are materials used for implants, not for in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostics.
In summary, the MultiFit Total Hip System is a medical device intended for surgical implantation to treat hip joint issues, not a device used for diagnostic testing outside of the body.
N/A
Intended Use / Indications for Use
The hip system is intended to be cemented stem or un cemented stem use. Indications for Use: The MultiFit Total Hip System is to replace a defective hip joint in the following cases: 1 ) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur; 2) Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; 3) Patients suffering from disability due to previous fusion and previously failed endo-prostheses; 4) Patients with acute femoral neck fractures.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, KWY, KWZ
Device Description
The MultiFitTM Total Hip System is total hip joint prosthesis which consists of stems, acetabular system, bipolar system and femoral head. Stems are available with two femoral designs. One is manufactured from Ti6A14V alloy which intended for non-cemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. All implant devices are designed for single use only and provided with separated sterilized package. Various sizes are available for each component. Femoral stems - Cementless stem (sizes 130 mm to 150 mm) and cement collared stem (sizes 110 mm to 128 mm) are intended to be used with the other components of the The MultiFitTM Total Hip Metal femoral heads - Metal femoral heads (22 mm and 28 mm in diameter) which is fabricated from Cobalt Chromium Molybdenum (CoCrMo) are intended to be used in conjunction with the commercially available press-fit Ti6Al4V or Co-Cr-Mo alloy Hip Stems cement type and cementless. Acetabular cups and UHMWPE liners - Acetabular cup is manufactured from Ti-6Al-4V ELI and Liner is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE). The UHMWPE insert (sizes 22 mm and 28 mm) are intended to be used in conjunction with MultiFitTM Total Hip System acetabular cups (sizes 42 mm to 60 mm in 2 mm increments) in cementless applications. UHMWPE liners are available in two types of Flat and 10° elevated. Bipolar cups and liners - Bipolar cup is made of Cobalt Chromium Molybdenum (CoCrMo) and liner is made of Ultra-High Molecular Weight Polyethylene (UHMWPE) same as acetabular liner. Bipolar cups (sizes 42 mm to 55 mm 1 mm increments) are intended to be used with the bipolar liners (22 mm and 28 mm in diameter) of the MultiFitTM Total Hip System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing as listed in Section 15 and Appendix D. was conducted in accordance with standard. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
List of the bench tests conducted for the substantial equivalence to the predicate devices:
-
- Ace tabular system Push out test of Locking Mechanism according to ASTM F1820
-
- Ball pull off test according to ASTM F2009
-
- Bone screw axial pullout strength test according to ASTM F543
-
- Bone screw torsion strength test according to the ASTM F543
-
- Range of motion test according to the ISO 21535
-
- Wear test according to the ISO 14242-1:2002-03 and ISO 14242-2:2000-10-()રે
-
- Fatigue test according to the ISO 7206-4(2002) Implants for surgery Partial and total hip joint prostheses - Part4: Determination of endurance properties of stemmed femoral components.
-
- Fatigue test according to the ISO 7206-6(1992)- Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
-
- Oxidation index and accelerated ageing of UHMWPE according to ASTM F2102-01el and ASTM F2003-02
-
- Ace tabular liner torsion test
-
- Ace tabular system Lever out test
-
- Bipolar system Push out test between ball and UHMWPE liner
-
- Bipolar system Lever out test between ball and UHMWPE liner
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.
K011489, K972641, K934765, K812672, K051569, K021673, K911684
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
KI01472
Premarket Notification 510(k) 5. 510(k) Summary
5. 510(k) Summary
[As Required by 21 CFR 807.87(h) & 21 CFR 807.92]
1. Submission information
Name of Company:
OTIS Biotech Co., Ltd FDA registration No. 3005140381 #514 Sihwa industrial complex 2Ba Block Jeongwang-Dong, Siheung-si Gyounggi-Do, Republic of Korea 429-450 Tel: 82-31-319-0406 Fax: 82-31-319-0414
Contact: srinivasareddy krotha
E-mail: srinivasareddy@otisbiotech.com Tel: 82-31-414-4618 Fax: 82-31-411-1076
Date Prepared: 10-05-2010
2. Device Identification
| Trade Name: | MultiFit TM Total Hip System |
|---|---|
| Common Name: | Total Hip Joint Prosthesis |
| Classification: | Class II (Special Control) |
| JDI 888.3350 - Prosthesis, Hip, Semi-Constrained, | |
| Metal/Polymer, Cemented. | |
| LZO 888.3353 -Hip joint metal/ceramic/polymer semi | |
| -constrained cemented or nonporous un cemented | |
| prosthesis | |
| KWY 888.3390 - Prosthesis, Hip, Hemi-, Femoral, | |
| Metal/Polymer, Cemented or Uncemented | |
| KWZ 888.3310 - Prosthesis, Hip, Constrained, | |
| Cemented or uncemented, Metal/Polymer |
3. Substantial Equivalence Predicate_Legally Marketed Devices
The substantial equivalence of this device is based on equivalence in
5 - 1
| Artificial Joint Research Center |
|---|
| OTISBiotech co., Ltd. |
1
MultiFit ™ Total Hip System
intended use, materials, designs and operational principles to the below listed predicate devices.
| OTIS Biotech Co., Ltd
MultiFit™ Total Hip System | Predicate Device | 510(k)
Approval
Number | Product
Code |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------|
| Cementless Tapered Stem | i ) Depuy Orthopaedicss, Inc.
Summit™ DuoFix™ Hip Prosthesis
ii) Osteonics corporation.
Osteonics Imnifit HA Hip stem series | K011489 | LPH |
| Cement Collared Stem | i ) Wright Medical Technology INC.
PERFECTA® IMC Hip System
ii) Smith & Nephew, Inc.
Synergy Cemented Hip stem | K972641 | JDI |
| Acetabular System | i ) Zimmer, Inc.
Trilogy Acetabular System
ii) Smith & Nephew, Inc.
Reflection Cross-linked UHMWPE
acetabular component | K934765 | LPH |
| Bipolar System | i ) Depuy, Inc.
Self-centering Hip prosthesis
ii) Biomet, Inc.
Ringloc Bi-polar acetabular
component | K812672 | KWY |
| | | K051569 | JID |
| Femoral Ball Head | i ) Smith & Nephew, Inc.
Total Hip Femoral Head - 12/14
Taper
ii ) Biomet, Inc.
Biomet Cobalt-chrome femoral
components | K021673 | LZO |
| | | K911684 | JDI |
| Bone Screw | Zimmer, Inc. Trilogy Acetabular System | K934765 | LPH |
Artificial Joint Research Center © OTISBiotech co., Ltd.
Page 1 of 5
2
4. Device Description
The MultiFit™ Total Hip System is total hip joint prosthesis which consists of stems, acetabular system, bipolar system and femoral head. Stems are available with two femoral designs. One is manufactured from Ti6A14V alloy which intended for non-cemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. All implant devices are designed for single use only and provided with separated sterilized package. Various sizes are available for each component.
Femoral stems - Cementless stem (sizes 130 mm to 150 mm) and cement collared stem (sizes 110 mm to 128 mm) are intended to be used with the other components of the The MultiFit™ Total Hip
Metal femoral heads - Metal femoral heads (22 mm and 28 mm in diameter) which is fabricated from Cobalt Chromium Molybdenum (CoCrMo) are intended to be used in conjunction with the commercially available press-fit Ti6Al4V or Co-Cr-Mo alloy Hip Stems cement type and cementless.
Acetabular cups and UHMWPE liners - Acetabular cup is manufactured from Ti-6Al-4V ELI and Liner is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE). The UHMWPE insert (sizes 22 mm and 28 mm) are intended to be used in conjunction with MultiFit™ Total Hip System acetabular cups (sizes 42 mm to 60 mm in 2 mm increments) in cementless applications. UHMWPE liners are available in two types of Flat and 10° elevated.
Bipolar cups and liners - Bipolar cup is made of Cobalt Chromium Molybdenum (CoCrMo) and liner is made of Ultra-High Molecular Weight Polyethylene (UHMWPE) same as acetabular liner. Bipolar cups (sizes 42 mm to 55 mm 1 mm increments) are intended to be used with the bipolar liners (22 mm and 28 mm in diameter) of the MultiFitTM Total Hip System.
Artificial Joint Research Center COTISBiotech co., Ltd.
5 - 3
Page 3 of 5
3
5. Indications for Use
The MultiFit Total Hip System is intended to be cemented stem or uncemented stem use.
The MultiFit Total Hip System is to replace a defective hip joint in the following cases:
-
Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
-
Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis
-
Patients suffering from disability due to previous fusion
-
Patients with acute femoral neck fractures
6. Statement of Technological Comparison
Bench testing as listed in Section 15 and Appendix D. was conducted in accordance with standard. It demonstrates substantial equivalence to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
Artificial Joint Research Center OTISBiotech co., Ltd.
5 - 4
4
7. List of the bench tests conducted for the substantial equivalence to the predicate devices
KID 1477
-
- Ace tabular system Push out test of Locking Mechanism according to ASTM F1820
-
- Ball pull off test according to ASTM F2009
-
- Bone screw axial pullout strength test according to ASTM F543
-
- Bone screw torsion strength test according to the ASTM F543
-
- Range of motion test according to the ISO 21535
-
- Wear test according to the ISO 14242-1:2002-03 and ISO 14242-2:2000-10-()રે
-
- Fatigue test according to the ISO 7206-4(2002) Implants for surgery Partial and total hip joint prostheses - Part4: Determination of endurance properties of stemmed femoral components.
-
- Fatigue test according to the ISO 7206-6(1992)- Implants for surgery -- Partial and total hip joint prostheses -- Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
-
- Oxidation index and accelerated ageing of UHMWPE according to ASTM F2102-01el and ASTM F2003-02
-
- Ace tabular liner torsion test
-
- Ace tabular system Lever out test
-
- Bipolar system Push out test between ball and UHMWPE liner
-
- Bipolar system Lever out test between ball and UHMWPE liner
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, abstract design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OTIS Biotech Co., Ltd % Mr. Srinivasareddy Krotha 514 Sihwa Industrial Complex 2Ba Block Jeongwang-Dong, Siheung-si Gyounggi-Do, Republic of Korea 429-450
JAN 5 2011
Re: K101472 Trade/Device Name: Multifit Total Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. Regulatory Class: Class II Product Code: LZO, JDI, KWY, KWZ Dated: December 24, 2010 Received: December 30, 2010
Dear Mr. Krotha
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
and the comments of the comments of
and the contraction of the country of the country of
6
Page 2 - Mr. Srinivasareddy Krotha
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ar
B. rh
fr.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K10472
4. Indications for Use
510(k) Number:
Device Name: MultiFit™ Total Hip System
The hip system is intended to be cemented stem or un cemented stem use. Indications for Use:
The MultiFit Total Hip System is to replace a defective hip joint in the following cases:
- l ) Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur;
-
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis;
-
- Patients suffering from disability due to previous fusion and previously failed endo-prostheses;
-
- Patients with acute femoral neck fractures.
Prescription Use Yes (Part 21 CFR 801 Subpart D) Over-The-Counter Use No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mikkerson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_
Artificial Joint Research Center OTISBiotech co., Ltd.