(88 days)
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.
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.
This 510(k) summary describes a modification to the Synergy Hip System, specifically the addition of tantalum markers. The information provided heavily focuses on the regulatory aspects and equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the traditional sense of a clinical trial for a novel device.
The "acceptance criteria" and "device performance" in this context are interpreted as the regulatory requirement for substantial equivalence to legally marketed predicate devices, with the modification (tantalum markers) not raising new questions of safety or effectiveness. The study demonstrating this is primarily a comparison to predicate devices and an explanation of the function of the added markers.
Here's an attempt to extract and structure the requested information based on the provided text, while acknowledging that a traditional clinical study with explicit acceptance criteria and performance metrics for the entire hip system is not detailed here. Instead, the focus is on the incremental change (tantalum markers) and its impact on substantial equivalence.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied Regulatory) | Reported Device Performance (as per submission) |
|---|---|
| New Safety/Effectiveness Concerns: No new questions of safety or effectiveness are raised by the modification. | The addition of tantalum markers is the only change. The intended use, design (other than markers), and materials of the Synergy Hip System are "substantially equivalent" to predicate devices. The tantalum markers are for Radiostereometric Analysis (RSA) to measure implant migration, implying an assessment of their intended function without causing harm. |
| Substantial Equivalence: The modified device (with tantalum markers) maintains substantial equivalence to legally marketed predicate devices. | The Synergy Hip System (with tantalum markers) is considered substantially equivalent to: - Smith & Nephew Synergy Global Taper Hip System (K963509, K991485, K002996) - Smith & Nephew Reflection Cross-Linked UHMWPE Acetabular Component (K002747) - Biomet Tantalum Bead, Radiographic Marker (K010348) - Encore Orthopedics Radiographic Marker (K011856) |
| Functional Purpose of Tantalum Markers: The markers enable Radiostereometric Analysis (RSA) for measuring implant migration/movement via radiographs. | The tantalum markers will allow the surgeon to perform radiostereometric analysis to measure implant migration or movement through radiographs. This statement describes the intended and presumed function of the markers. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable or not specified for a traditional clinical "test set" in this submission. The "test" for substantial equivalence is primarily a comparison of design, materials, and intended use against predicate devices, rather than a performance study on a specific number of patients.
- Data Provenance: Not applicable in the context of a prospective or retrospective clinical study on the modified device itself. The data provenance implicitly relies on the regulatory approval and safety/effectiveness data of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Interpretation: For a 510(k) submission, the "ground truth" for substantial equivalence is established by the FDA's regulatory review process and comparison to existing, legally marketed devices. This process involves FDA reviewers (experts in medical device regulation and relevant scientific fields) evaluating the submitted documentation.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The FDA's review process acts as the ultimate "adjudication" for substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, this is not applicable. The device is a hip implant system, not an AI-assisted diagnostic or imaging device. The tantalum markers aid in a measurement technique (radiostereometric analysis) performed by a clinician, but the submission does not describe an MRMC study comparing human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, this is not applicable. This device is a physical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" here is the regulatory determination of substantial equivalence to previously cleared predicate devices. This relies on the established safety and effectiveness of those predicate devices, which would have been supported by their own ground truth data (e.g., historical clinical performance, mechanical testing, material compatibility, and potentially some outcomes data depending on their clearance pathway). For the tantalum markers specifically, their ability to enable RSA is a known radiographic technique, and the functional ground truth is that they are visible and aid in a measurement.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- How Ground Truth for Training Set was Established: Not applicable. There is no training set for this device.
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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 cementedor uncemented prosthesis | |
| 21 CFR 888.3353, | |
| Hip Joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis | |
| 21 CFR 888.3358, | |
| Hip Joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis | |
| 21 CFR 787.4300, | |
| Implantable Clip | |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87/LPH, MEH, JDI, LZOGeneral 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
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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).
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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
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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
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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
§ 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.