(59 days)
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No
The 510(k) summary describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities. The focus is on the physical components and their mechanical performance.
No.
The device is an orthopedic implant for total hip arthroplasty, which is a surgical procedure, not a therapeutic device in itself.
No
The device is a modular hip system for total hip arthroplasty, and its indicated uses are for treatment, not diagnosis. It is a prosthetic implant, not a diagnostic tool.
No
The device description clearly states it is a modular hip system comprised of physical components (proximal body styles, distal stem designs, locking bolt) intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement (total hip arthroplasty) and related procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a modular hip system comprised of physical components (proximal body styles, distal stem designs, locking bolt) that are assembled and implanted into the patient. This is consistent with a surgical implant.
- 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.
Therefore, the Restoration® Modular System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restoration Modular System include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes (comma separated list FDA assigned to the subject device)
87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY, and 87 KWL
Device Description
The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Cone Body to create a new style of proximal body called the Restoration® Modular Calcar Body for use with the previously cleared Restoration® Modular Distal Stem components.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
proximal femur
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
Not Found
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)
Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength.
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.
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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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K050138 (pg 10
Line Extension to the Restoration® Modular Hip System
MAR 2 1 2005
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Restoration Modular Hip System
| Proprietary Name: | Restoration® Modular System |
|---|---|
| Common Name: | Femoral Hip Prosthesis |
| Proposed Regulatory Class: | Class II |
| Classification: | Hip joint metal/ceramic/polymer semi-constrained cemented or |
| nonporous uncemented prosthesis, 21 CFR §888.3353, | |
| Hip joint metal/polymer semi-constrained cemented prosthesis, 2 | |
| CFR §888.3350 | |
| Hip joint metal/polymer/metal semi-constrained porous-coated | |
| uncemented prosthesis, 21 CFR §888.3358 | |
| Hip joint metal/polymer constrained cemented or uncemented | |
| prosthesis, 21 CFR §888.3310 | |
| Hip joint femoral (hemi-hip) metal/polymer cemented or | |
| uncemented prosthesis, 21 CFR §888.3390 | |
| Hip joint femoral (hemi-hip) metallic cemented or uncemented | |
| prosthesis, 21 CFR §888.3360 | |
| Device Product Code: | 87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY, |
| and 87 KWL | |
| For Information contact: | Karen Ariemma |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: karen.ariemma@stryker.com | |
| Date Summary Prepared: | January 19, 2005 |
1
Line Extension to the Restoration® Modular Hip System
Special 510(k) Premarket Notification
Device Description
The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Cone Body to create a new style of proximal body called the Restoration® Modular Calcar Body for use with the previously cleared Restoration® Modular Distal Stem components.
Indications for Use
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restoration Modular System include: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Substantial Equivalence
The features of the new components are substantially equivalent to the predicate devices based on similarities in intended use, materials and design. Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical.
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 features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
MAR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics, Corp. 325 Corporate Drive Mahwah. New Jersey 07430
Re: K050138
Trade/Device Name: Restoration® Modular System Regulation Number: 21 CFR 888.3353, 21 CFR 888.3350, 21 CFR 888.3358, 21 CFR 888.3310. 21 CFR 888.3390, and 21 CFR 888.3360 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis; Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis; Hip joint metal/polymer constrained cemented or uncemented prosthesis; Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis; and Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II Product Code: LZO, MEH, JDI, LPH, KWZ, KWY, KWL, LWJ Dated: January 19, 2005 Received: January 21, 2005
Dear Ms. Ariemma:
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.
3
Page 2 - Ms. Karen Ariemma
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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.
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millmann
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOS0138 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Restoration® Modular System
Indications For Use:
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restoration® Modular System include:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular . necrosis,
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, and .
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative and Neurological Devices
| Page | 1 of 1 |
|---|---|
| 510(k) Number | K050138 |