(149 days)
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Not Found
No
The document describes a mechanical hip prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended to alleviate pain and restore function in total hip arthroplasty, which are therapeutic goals.
No
This device is a prosthetic implant (Stryker Modular Hip System) used in total hip arthroplasty to alleviate pain and restore function, not to diagnose a condition.
No
The device description clearly states it is a "modular hip prosthesis" and a "modular stem with a modular neck," which are physical hardware components intended for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant - a modular hip prosthesis intended to be surgically implanted into the body to replace a damaged hip joint.
- Intended Use: The intended use is for "primary and revision total hip arthroplasty to alleviate pain and restore function," which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a medical device, but it falls under the category of implantable devices or surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Stryker Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acetabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
-
- Rheumatoid arthritis:
-
- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal 2) femur with head involvement that are unmanageable using other techniques.
The Stryker Modular Hip System is intended for cementless use only.
Product codes (comma separated list FDA assigned to the subject device)
87 MEH, 87 LZO, 87 LPH, 87 JDI, 87 KWY, 87 KWZ, 87 KWL, 87 LWJ
Device Description
Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the Stryker Modular Hip System is similar to other total hip systems commercially distributed such as the Profemur® Total Hip Modular Neck System, Wright Medical Technology, Inc. and other Howmedica Osteonics' hip systems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems and the Citation TMZF HA Stem.
The subject hip is a composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based upon the mechanical testing, the Stryker Modular Hip is substantially equivalent for its intended use to other press-fit femoral replacement hips currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
SEP 1 3 2007
K071082
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | Stryker Modular Hip System |
|---|---|
| Common Name: | Hip prosthesis |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained |
| cemented or nonporous uncemented prosthesis, 21 CFR | |
| §888.3353 | |
| Hip joint metal/polymer/metal semi-constrained porous | |
| coated uncemented prosthesis, 21 CFR §888.3358 | |
| Hip joint metal/polymer semi-constrained cemented | |
| prosthesis 21 CFR §888.3350 | |
| Hip joint femoral (hemi-hip) metal/polymer cemented or | |
| uncemented prosthesis. 21 CFR §888.3390 | |
| Hip joint metal/polymer constrained cemented or | |
| uncemented prosthesis. 21 CFR §888.3310 | |
| Hip joint femoral (hemi-hip) metallic cemented or | |
| uncemented prosthesis. 21 CFR §888.3360 | |
| Regulatory Class: | Class II |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, |
| uncemented, metal/polymer, non-porous, calcium- | |
| phosphate | |
| 87 LZO - prosthesis, hip, semi-constrained, | |
| metal/ceramic/polymer, cemented or non-porous, | |
| uncemented | |
| 87 LPH - prosthesis, hip, semi-constrained, | |
| metal/polymer, porous uncemented | |
| 87 JDI - prosthesis, hip, semi-constrained, | |
| metal/polymer, cemented | |
| 87 KWY - prosthesis, hip, hemi-, femoral, | |
| metal/polymer, cemented or uncemented | |
| 87 KWZ - prosthesis, hip, constrained, cemented or | |
| uncemented, metal/polymer | |
| 87 KWL - prosthesis, hip, hemi-, femoral, metal | |
| 87 LWJ - prosthesis, hip, semi-constrained, | |
| metal/polymer, uncemented | |
| For Information contact: | Vivian Kelly, Senior Regulatory Affairs Specialist |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-5581 Fax: (201) 831-6038 |
1
September 7, 2007
Date Prepared:
Description:
Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the Stryker Modular Hip System is similar to other total hip systems commercially distributed such as the Profemur® Total Hip Modular Neck System, Wright Medical Technology, Inc. and other Howmedica Osteonics' hip systems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems and the Citation TMZF HA Stem.
The subject hip is a composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with currently available Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.
Intended Usc
The Stryker Modular Hip is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available Howmedica Osteonics acetabular components, V40 femoral heads, C-Taper Alumina heads when used with the V40/C-Taper Adaptor and the Biolox® Delta Universal Taper Heads and sleeves.
Indications:
The indications for use of total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
-
- Rheumatoid arthritis:
-
- Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal ર) femur with head involvement that are unmanageable using other techniques.
The Stryker Modular Hip System is intended for cementless use only.
Substantial Equivalence:
The Stryker Modular Hip is substantially equivalent to other commercially available hip systems in regards to intended use, design, materials, and operational principles as a hip prosthesis. The following devices are examples of predicate systems: the Profemure Total Hip Modular Neck System, Wright Medical Technology, Inc., and other Howmedica Osteonics hip stems such as the Secur-Fit HA Stem, the Accolade C and TMZF HA Stems, and the Citation TMZF HA Stem. Based upon the mechanical testing, the Stryker Modular Hip is substantially equivalent for its intended use to other press-fit femoral replacement hips currently on the market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or lines extending from the head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Public Health Service
SEP 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Howmedica Osteonics Corp. c/o Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K071082 Trade/Device Name: Stryker 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, MEH, LZO, LPH, JDI, KWZ, KWL, KWY Dated: August 24, 2007 Received: August 27, 2007
Dear Ms. Kelly:
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 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.
3
Page 2 - Ms. Vivian Kelly
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
barbere Buehmp
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Stryker Modular Hip System
Indications for Use:
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including ostcoarthritis and avascular ﺮ ﺍﻟﻤﺘﺤﺪﺓ
ﻭﺍﻟﺘﻲ necrosis: - Rheumatoid arthritis 产品
- Correction of functional deformity; े क
- Revision procedures where other treatments or devices have failed; and, ের মাধ্যমে সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সামগ্রী সা
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal in femur with head involvement that are unmanageable using other techniques.
The Stryker Modular Hip System is intended for cementless use only.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Nbaare fonchm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page I of I
510(k) Number K071062