(128 days)
Not Found
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a medical implant (hip system) designed to replace or revise impaired hip joints, not to provide therapy in the traditional sense of treating disease or conditions without surgical intervention. While it addresses medical conditions, its function is structural replacement rather than therapeutic.
No
The device is described as "UNISYN™ HIP SYSTEM" and is composed of a "Body, HA Plasma, Modular Hip" which are parts of a hip replacement system. Its indications for use are for conditions requiring surgical intervention due to impaired joints or fractures, not for diagnosing them.
No
The device description clearly describes a physical implantable hip system consisting of a body, neck, and stem, with surface coatings. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The indications for use clearly describe a surgical implant for treating various hip conditions. This involves direct intervention on the patient's body.
- Device Description: The device is described as a "Body, HA Plasma, Modular Hip" which is part of a modular hip system consisting of a neck, body, and stem. This is a physical implant designed to be surgically placed in the hip joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Indications for use of the UNISYN™ HIP SYSTEM
- A ) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
- B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa valga, developmental conditions, metabolic and turnorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Product codes (comma separated list FDA assigned to the subject device)
LWJ, JDI, LZO, MEH, LAJ
Device Description
The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Not Found
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.
K003649, K935453, K022549, K022463
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
K062383 - Third Revised Section 9 510(k) Summary of Safety and Effectiveness
Defined in 21 CFR 807 In accordance with 21 CFR 807.92 (Summary)
| Applicant's Name: | Hayes Medical, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95682 | DEC 21 2001 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Luke Rose | |
| Trade Name: | Body, UniSyn Modular Hip | |
| Common Name: | Body, HA Plasma, Modular Hip | |
| Classification Name: | Prosthesis, Hip, Semi-Constrained, Metal/Polymer,
Uncemented (21 CFR 888.3360, LWJ)
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
(21 CFR 888.3350, JDI)
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,
Cemented or Non-Porous, Uncemented (21 CFR 888.3353, LZO)
Prosthesis, Hip, Semi-Constrained, Uncemented,
Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353, MEH) | |
| Proposed Regulatory Class: | Class II | |
| Device Classification Panel: | Orthopaedic | |
| Substantially Equivalent To: | Hayes Medical Unisyn Modular Hip System (K003649)
Hayes Medical HA Coated Consensus Hip System (K935453)
Howmedica/Osteonics, Restoration Modular System (K022549)
Biomet Orthopedics, Inc., HA Modular Reach Proximal Porous (K022463) | |
Intended Use:
Indications for use of the UNISYN™ HIP SYSTEM
- A ) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
- B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
- C) Proximal femoral fractures.
- D) Avascular necrosis of the femoral head.
- E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa valga, developmental conditions, metabolic and turnorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities.
Device Description:
The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.
1
K062383 - Third Revised Section 9 510(k) Summary of Safety and Effectiveness
Comparison to Cleared Device:
The only change made to the previously cleared UniSyn Hip System (K003649) is the addition of hydroxylapatite coating to the existing TPS coating on the surface of the bodies.
Substantial Equivalence Information
The intended use, material, design features and type of interface of the Body, HA Plasma, Modular Hip are substantially equivalent to Hayes Medical and competitive devices previously cleared for market. The safety and effectiveness of the Body, HA Plasma, Modular Hip are adequately supported by the substantial equivalence information and materials data provided within this Special 510(k) submission.
2
510(K) ROUTE SLIP SPECIAL 510(k) NUMBER: K062383 PANEL: OR DIVISION: DGRND BRANCH: OJDB ELECTRONIC SUBMISSION: N TRADE NAME: UNISYN HA PLASMA MODULAR HIP COMMON NAME: BODY, HA PLASMA, MODULAR HIP PRODUCT CODE: LAJPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCE APPLICANT: HAYES MEDICAL, INC. SHORT NAME: HAYEMEDI CONTACT: LUKE ROSE DIVISION: ADDRESS: 1115 WINDFIELD WAY, SUITE 100 EL DORADO HILLS, CA 957629623 PHONE NO. (916) 355-7156 FAX NO. (916) 355-7190 MANUFACTURER: HAYES MEDICAL, INC. REG NO. 2952369 STERITEC, INC. 1647149 BIO-COAT, LLC 1833658 DATE ON SUBMISSION: 10-AUG-2006 DATE DUE POS: 09-SEP-2006 DATE RECEIVED IN ODE: 15-AUG-2006 DATE DECISION DUE: 14-SEP-2006 DECISION: ____________________________________________________________________________________________________________________________________________________________________ DECISION DATE: RECEIVED DUE POS SUPPLEMENTS SUBMITTED DUE OUT 27-SEP-2006 SOOI 25-SEP-2006 22-OCT-2006 27-OCT-2006 24-OCT-2006 11-DEC-2006 12-DEC-2006 06-JAN-2007 11-JAN-2007 S002 CORRESPONDENCE SENT DUE BACK COOL 06-SEP-2006 06-OCT-2006 HOLD LETTER C002 24 -OCT-2006 22-DEC-2006 HOLD LETTER
Is this 510(k) identified as a Class III device YES NO Is this 510(k) the result of additional information YES NO
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hayes Medical, Inc. % Dr. Luke Rose Director, OS&RA 1115 Windfield Way Suite 100 El Dorado Hills, California 95762
DEC 2 1 2006
Re: K062383
Trade/Device Name: UniSyn Modular Hip System Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, LZO, JDI, MEH Dated: December 11, 2006 Received: December 12, 2006
Dear Dr. Rose:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the
4
Page 2 - Dr. Luke Rose
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buehrig
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
UniSyn Modular Hip System Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Indications for use of the UNISYN™ HIP SYSTEM
A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis.
B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures.
C) Proximal femoral fractures.
D) Avascular necrosis of the femoral head.
E) Non-union of proximal femoral neck fractures.
F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities
Prescription Use _X ________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saubare Buell
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K062383