(75 days)
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Not Found
No
The summary describes a hip stem implant and its intended use, material, and design. There is no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The device is a total hip component, specifically a hip stem, which is used in surgery to rehabilitate damaged hips. This falls under the definition of a therapeutic device as it is intended to treat a condition (damaged hips) and restore function.
No
This device, a hip stem, is an implant used in surgery to replace damaged hips. Its purpose is treatment, not diagnosis. The "Indications for Use" describe conditions that necessitate the use of the hip stem, not conditions that the device itself diagnoses.
No
The device description clearly states it is a physical hip stem manufactured from titanium material, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a total hip component, specifically a hip stem, which is an implantable device used in surgery to replace a damaged hip joint. It is used in vivo (within the body) during a surgical procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is a physical implant.
Therefore, based on the provided information, the Synergy Porous Size 8 Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Total hip components are indicated for uncemented 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 (NIDJ) 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 osteomyclitis 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; fernoral osteotomy, or Girdlestonc resection; fracture dislocation of the hip; and correction of deformity.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO
Device Description
The Synergy Porous Size 8 Hip Stem is manufactured from titanium material (Ti-6AI-4V, ASTM F1472) and is designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
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
Hip
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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).
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§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
510(k) Summary
Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary device name: Common or usual name:
Classification name:
Smith & Nephew, Inc. 1450 Brooks Road, Memphis, TN 38116 901-399-6487 David Henley April 23, 1999 Synergy Porous Size 8 Hip Stem Syncrgy Forous ont - Porous Tapered Hip Stem
21 CFR 888.3358 hip joint metal/polymer/metal semi-21 CFR 866.5578 mp John mean posted uncemented prosthesis-Class II 87LPH
Substantially Equivalent Legally Marketed Devices
- Global Taper "Tapered" Hip Stem Smith & Nephew .
- Revision (Echelon) Hip Stem Smith & Nephew . �
- Versys® Hip Stem Zimmer .
- Perfecta IMCTM Hip Stem Wright Medical �
- AML® Hip Stem DePuy ●
Device Description
Device Description
The Synergy Porous Size 8 Hip Stem is manufactured from titanium material (Ti-6AI-4V, ASTM F1472) The Synergy Porous Size o Hip Stein is nambidered from in them.
and is designed for use with existing cobalt chrome or ceramic modular femoral heads with a 12/14 taper.
Device Intended Use
Device Intended Use I of a mp components are indicated ancements associations hips damaged as a result of trauma,
surgery where other treatments or devices have failed in rehabilitation inint di surgery where other treatments of devices have in rendemannatory degeneration in disease inflammatory Joint disease such as medification in the recosis, traumatic arthoritos (NIDD) of any of Its composite uraginses such as estocal director of tremote of the province of the provimal silpped capital epiphysis, fused inf, fracture of the period tractures of the proximal
an extended drainage-free period; nonunion, femoral neck fractures fractores of the pro all extended dramage-free period, nonanageable using other techniques; femoral osteotomy, or femal with nead in Forrement dislocation of the hip; and correction of deformity.
The Synergy Porous Size 8 Hip Stem is designed for single use only.
Technological characteristics:
The Synergy Porous Size 8 Hip Stem is similar to the legally marketed devices listed above. All of these I he Synergy I Grous Gree of Thp Seem is Smith, as with of the Synergy Porous Size 8 Hip Stem and have the same technological characteristics.
Performance characteristics:
x croomance that the Synergy Porous Size 8 Hip Stem is 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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 1999
Mr. David Henley Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Rd. Memphis, Tennessee 38116
Re: K991485
Trade Name: Synergy porous Size 8 Hip Stem Regulatory Class: II Product Code: LPH and LZO Dated: April 27, 1999 Received: April 28, 1999
Dear Mr. Henley:
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 commercc 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 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 (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. A 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: 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. David Henley
This letter will allow you to begin marketing your device as described in your 510(k) promated I his letter will anow you to begin marketing your device to a legally marketed nothication. The PDA inding of succemar vqur device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and II you desire specific advice for your dones), please contact the Office of Compliance at additionally 609.10 for in vitty diagnostions on the promotion and advertising of your device, (301) 594-4037. Addinonally, for questions on assisted on associated the regulation prease contact the Office or Comphanee at (301) of the other (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnes ander the rice may of -2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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 Porous Size 8 Hip Stem
Total hip components are indicated for uncemented 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 (NIDJ) 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 osteomyclitis 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; fernoral osteotomy, or Girdlestonc resection; fracture dislocation of the hip; and correction of deformity.
signature
Orvision Sid vision of General Re 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Syncrgy Porous Sz. 8 Hip Stem CONFIDENTIAL