(88 days)
Not Found
No
The device description focuses on the physical components and their use in surgery and radiographic analysis, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for treating damaged hips due to trauma, degenerative joint disease, and other conditions, which are therapeutic purposes.
No
The device is a hip implant system used for surgical intervention, not for diagnosing medical conditions. It includes tantalum markers that allow the surgeon to measure implant migration or movement through radiographs, which is a post-operative assessment rather than a diagnostic function.
No
The device description explicitly states it includes "Femoral Components with tantalum markers and acetabular component liners with tantalum markers," which are physical hardware components.
Based on the provided information, the Synergy Hip System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Synergy Hip System Function: The Synergy Hip System is a hip implant used in surgical procedures to replace or repair damaged hip joints. It is an implantable medical device, not a device that analyzes biological samples.
- Tantalum Markers: While the device includes tantalum markers for radiostereometric analysis (which uses radiographs to measure implant movement), this analysis is performed on the implant itself within the patient's body, not on a biological specimen taken from the patient.
Therefore, the Synergy Hip System falls under the category of an implantable surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Synergy Hip System is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, JDI, MEH, NEU, FZP
Device Description
The Synergy Hip System includes Synergy Hip System Femoral Components with tantalum markers and acetabular component liners with tantalum markers. The addition of tantalum markers is the only change between the predicate devices and the devices included in this submission. The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographs
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital
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.
K963509, K991485, K002996, K002747, K010348, K011856
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
JUL 1 4 2006
510(k) Summary Synergy Hip System
| Submitter's Name: | Smith & Nephew, Inc., Orthopaedics |
|---|---|
| Submitter's Address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's Telephone Number: | 901-399-6670 |
| Contact Person: | John Reabe |
| Date Summary Prepared: | April 7, 2006 |
| Trade or Proprietary Device Name: | Synergy Hip System |
| Common or Usual Name: | Hip joint prosthesis |
| Classification Name: | |
| 21 CFR 888.3350, | |
| Hip Joint metal/polymer semi-constrained cemented | |
| or uncemented prosthesis | |
| 21 CFR 888.3353, | |
| Hip Joint metal/ceramic/polymer semi-constrained | |
| cemented or nonporous uncemented prosthesis | |
| 21 CFR 888.3358, | |
| Hip Joint metal/polymer/metal semi-constrained | |
| porous-coated uncemented prosthesis | |
| 21 CFR 787.4300, | |
| Implantable Clip | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87/LPH, MEH, JDI, LZO |
| General and Plastic Surgery/79/NEL, EZP |
Device Description
The Synergy Hip System includes Synergy Hip System Femoral Components with tantalum markers and acetabular component liners with tantalum markers. The addition of tantalum markers is the only change between the predicate devices and the devices included in this submission. The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs.
Intended Use
The Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are
1
unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Synergy Hip System is intended for single use only.
Substantial Equivalence
The intended use, design, and materials of the Synergy Hip System are substantially equivalent to the Smith & Nephew Synergy Global Taper Hip System (K963509, K991485 and K002996), Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component (K002747), Biomet Tantalum Bead, Radiographic Marker (K010348) and Encore Orthopedics Radiographic Marker (K011856).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings at the top. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 2006
Mr. John Reabe Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K061066
Trade/Device Name: Synergy 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 Codes: LZO, LPH, JDI, MEH, NEU, FZP Dated: June 22, 2006 Received: June 23, 2006
Dear Mr. Reabe:
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
3
Page 2 - Mr. John Reabe
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Aarlene Mueller
Mark N. Melkerson, M.S. 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): KO61066
Device Name: Synergy Hip System
Indications for Use:
The Synergy Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The Synergy Hip System is also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.
The Synergy Hip System is intended for single use only.
Prescription Use x (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)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
neral. Restorative. and Neurological Devices
510(k) Number K061066