(29 days)
Not Found
Not Found
No
The summary describes a mechanical hip implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended for total hip arthroplasty to treat various conditions like osteoarthritis and avascular necrosis, which falls under therapeutic intervention.
No
The device description indicates it is a modular hip system for total hip arthroplasty, which is a therapeutic treatment. There is no mention of it being used to diagnose a medical condition.
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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the hip joint for total hip arthroplasty and revision procedures. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is a modular hip implant system comprised of physical components (proximal bodies and distal stems) that are assembled and implanted. This is a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
Therefore, the Restoration® Modular System is a surgical implant device, 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. 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 .
AND/OR
- 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 Bowed Plasma Stem to create a line extension called the Restoration® Modular Bowed Plasma Trislot Stem. The subject components are for use with the previously cleared Restoration® Modular Distal Stem components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, Femoral (hemi-hip), Proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon in the operating room.
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
Not Found
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.
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
§ 888.3350 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
Line Extension to the Restoration® Modular Hip System
K051363 p1/2
Special 510(k) Premarket Notification
JUN 2 3 2005
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, | |
| Prosthesis, hip, semi-constrained, metal/polymer, uncemented, 21 | |
| 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 |
| Senior 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: | May 24, 2005 |
1
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 Bowed Plasma Stem to create a line extension called the Restoration® Modular Bowed Plasma Trislot Stem. The subject components are 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. 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
Public Health Service
Image /page/2/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
JUN 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K051363
Trade/Device Name: Restoration® Modular System_ Regulation Number: 21 CFR 888.3310, 888.3353, 888.3350. 888.3360, 888.3390 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis, 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 femoral (hemi-hip) metallic cemented or uncemented prosthesis, Hip joint femoral (Hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II
Product Code: JDI, LWJ, MEH, LZO, LPH, KWZ, KWY, KWL Dated: May 24, 2005 Received: May 25, 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 I lease oc advisou that I Drainstan that your device complies with other requirements of the Act that I Dr has made a wond regulations administered by other Federal agencies. You must or any I vith 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 Of It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis) of the provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and in your he FDA finding of substantial equivalence of your device to a legally premaince noticated.com "The 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 If you active 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 other general mionnal 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,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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. 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 .
AND/OR
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.
Prescription Use
(Part 21 CFR 801 Subpart D)
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) Page 1 of of 1_ Sion Sign-Off) ision of General, Restorative and Neurological Devices
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