(32 days)
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Not Found
No
The summary describes a traditional hip implant device made of forged cobalt chrome, with no mention of AI, ML, image processing, or any data related to training or testing of algorithms.
No
The device is a hip implant, which replaces damaged hip components to restore function, rather than provide therapy to treat a disease or condition.
No
The document describes a hip stem, which is an implant used in hip replacement surgery, not a device intended to diagnose medical conditions.
No
The device description clearly states the device is a physical hip stem manufactured from forged cobalt chrome material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided information describes a surgical implant (total hip components/hip stems) made of metal, designed to be surgically implanted into the body to replace a damaged hip joint.
- Intended Use: The intended use clearly states that the device is for surgical implantation in individuals undergoing hip replacement surgery.
The device is a medical device, but it is an implantable surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Total hip components are indicated cemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Synergy Cemented Hip Stems are designed for single use only.
Product codes
JDI
Device Description
The Synergy Cemented Hip Stems are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data indicate that the Synergy Cemented Hip Stems are substantially equivalent to legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Global Taper "Tapered" Hip Stem Smith & Nephew, Zimmer Versys® Hip Stem Zimmer, Wright Perfecta IMC™ Hip Stem Wright Medical, Spectron Extra Small Straight Femoral Component Smith & Nephew, DePuy AML® Hip Stem DePuy
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
3/12/99
K99 0369
510(k) Summary
Smith & Nephew, Inc. 1450 Brooks Road, Memphis, TN 38116 901-399-5363 Neal Defibaugh February 23, 1999 Synergy Cemented Hip Stems Prosthetic Hip Joint - Nonporous Tapered Hip Stem
21 CFR 888.3350 hip joint metal/polymer/metal semiconstrained cemented prosthesis-Class II, 87JDI
Substantially Equivalent Legally Marketed Devices
Submitter's name:
Contact person:
Submitter's address:
Date summary prepared:
Common or usual name:
Classification name:
Submitter's telephone number:
Trade or proprietary device name:
- Global Taper "Tapered" Hip Stem Smith & Nephew .
- Zimmer Versys® Hip Stem Zimmer ●
- Wright Perfecta IMC™ Hip Stem Wright Medical .
- Spectron Extra Small Straight Femoral Component Smith & Nephew .
- DePuy AML® Hip Stem DePuy .
Device Description
The Synergy Cemented Hip Stems are manufactured from forged cobalt chrome (CoCr) material (ASTM F799) and are designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
Device Intended Use
Total hip components are indicated cemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
The Synergy Cemented Hip Stems are designed for single use only.
Technological characteristics:
The Synergy Cemented Hip Stems are similar to the legally marketed devices listed above. All of these devices are indicated for total hip replacement, are similar in design to the Synergy Cemented Hip Stems and have the same technological characteristics.
Performance characteristics:
Data indicate that the Synergy Cemented Hip Stems are substantially equivalent to legally marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 1999
Mr. Neal Defibaugh Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
K990369 Re: Synergy Cemented Hip Stems Trade Name: Requlatory Class: II Product Code: JDI February 5, 1999 Dated: February 8, 1999 Received:
Dear Mr. Defibaugh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੀ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Neal Defibaugh
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witten, Ph.D. M.D.
2 Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications Statement Synergy Cemented Hip Stems
Mo369
Total hip components are indicated for cemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use > (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Pecellfo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990631