(107 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip component indicated for primary and revision surgery to rehabilitate hips damaged by various conditions, which aligns with the definition of a therapeutic device.
No
The device description clearly states it is a "Total hip component" and "The Smith & Nephew Platform Hip Stem features a 12/14 taper and is used with existing Smith & Nephew femoral heads and acetabular components." This indicates it is an orthopedic implant used for hip replacement surgery, not a diagnostic tool. The "Intended Use / Indications for Use" section further details its use in "primary and revision surgery" for "rehabilitating hips damaged as a result of trauma, inflammatory joint disease," which aligns with a therapeutic, rather than diagnostic, purpose.
No
The device description clearly states it is a physical hip stem manufactured from Ti-6Al-4V, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical implantation to replace damaged hip joints. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The description details a physical implantable device made of Ti-6Al-4V, designed to be surgically placed in the hip. This is consistent with a medical device for implantation, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, or controls, which are all hallmarks of IVD devices.
This device is a medical device specifically a total hip component for surgical implantation.
N/A
Intended Use / Indications for Use
Total hip components are indicated for uncemented use 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. Smith & Nephew Platform Hip Stem components are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO, JDI, LWJ
Device Description
The Smith & Nephew Platform Hip Stem features a 12/14 taper and is used with existing Smith & Nephew femoral heads and acetabular components. The Platform Hip Stem is manufactured from Ti-6Al-4V conforming to ASTM F 136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
A review of the test report data indicated that the Smith & Nephew of with and A review of the test report data indicated and is capable of withstanding expected in vivo loading without failure.
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.
K030373, K963509, K991485, K042127, K002996
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
Smith & Nephew, Inc. Summary of Safety and Effectiveness Smith & Nephew Platform Hip Stem
DEC 7 2005
Date of Summary: August 19, 2005
Contact Person and Address Gino Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-6707
Name of Device: Smith & Nephew Platform Hip Stem Common Name: Prosthetic hip joint
Device Description
Device Description The Smith & Nephew I fattorin The Stem features a 12/14 taper and is used with circulouralpezondar neek geomed y. Trade and acetabular components. The Platform
existing Smith & Nephew femoral heads and acetabular components. 126 existing Sintti & Nophow Tom Ti-6Al-4V conforming to ASTM F 136.
Device Classification
Device Classification
21 CFR 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis – Class II
Class II
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II
Mechanical and Clinical Data
Mechanical and Chinear Data
A review of the test report data indicated that the Smith & Nephew of with at and A review of the test report data marcated and is capable of withstanding expected in vivo loading without failure.
Indications for Use
Indications for USE
Total hip components are indicated for uncemented use in individuals undergoing Total hip components are increated for anteased in antestant or devices have failed in primary and revision stagery where other trauma, inflammatory joint disease such as
rehabilitating hips damaged as a result of trauma, inflammace (AJID) or any rehabilitating inps damaged as a result of themes and the joint disease (NIDID) or any
rheumatoid arthritis, or nonin'Ilammatory degenerative joint disease (NIDIO) or any
ati of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic of its composite diagnoses such as ontocal in fracture of the pelvis; diastrophic arthritis; slipped capital epith sistem inp; inced inp; included drainage-free period; nonunity hond variant; old, remote osteonlychtle with & was and the proximal femur with head. femoral neck fracture and trochanterie in other techniques; femoral osteotomy, of
involvement that are unmanageable using other techniques; of deformity involvement that are unmanagedore asing of the hip; and correction of deformity. Girdlestone resection, fracture assisted as a for single use only.
Substantial Equivalence Information
Substantial Equivalence of the Smith & Nephew Platform Hip Stem is based on its similarities in indications for use, design features, operational principles, and its similarities in mulcations for use, design rote devices – Plus Orthopedics SLmaterial composition to the following predicate devices – Plus Orther Alleon material composition to the following predicate devices - Services - Services Alloclassic
1
Zweymuller SL/SLL Femoral Hip Stems (K030373), Smith & Nephew Modular Hip
Stepher States (Kenthe Suritis & Nephaw Sustem (K963509), K991485 Zweymuller SL/SLL Femoral Hip Stems (R050573), Shiftin Corregion (K963509, K991485,
Stem (K042127) and the Smith & Nephew Synergy Hip System (K963509, K991485,
Stem (K042127) and K002996).
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC ?
Gino J. Rouss Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K052275
K03273
Trade/Device Name: Smith & Nephew Platform Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, JDI, LWJ Dated: November 17, 2005 Received: November 21, 2005
Dear Mr. Rouss:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device is substantials; in interests referenced above and have determined the arresed predicate devices marketed in interstate for use stated in the enclosure) to regary mancede producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderal Food. Drug commerce prof to May 20, 1970, the chacinent and second of the Federal Food. Drug, devices that have been reciassified in accordance with approval application (PMA).
and Cosmetic Act (Act) that do not require approval assessed approval application of the Ac and Cosment Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the devreet, belyer to the s
general controls provisions of the Act include requirements for answer michrending and general controls provisions of the Helens - and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into ennier regulations affecting your device can
may be subject to such additional controls. Existing major regulations all any may be subject to such additional controller Entitle of Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 and 11 be found in the Code of Peachal Negarding your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuates of a subscription with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination administered by other Federal agencies. You must or any Federal statures and regulations administered or registration and listing (21
comply with all the Act's requirements, including, but not limited to: set comply with an the Act S requirements, mercesses wouldeduring practice requirements as set CFR Part 807), rabening (21 CFR Part 600); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Gino J. Rouss
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin manteang your and equivalence of your device to a legally premits that notheation. The PDA mining of casting of 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 desire specific advice for your donee of (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comphaller and (21 transmit (21CFR Part 807.97). You may obtain Missuranuing o'y reference to premains to premails the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Z
Ser
Mark N. Melkerson Acting 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): k (0) 2275
Device Name: Smith & Nephew Platform Hip Stem
Indications for Use:
Total hip components are indicated for uncemented use in individuals undergoing primary and rolar hip compensions ar ther 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. Smith & Nephew Platform Hip Stem components are for single use only.
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Co
121 CFR 807.9
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)
(Division Sign=1 Division of General, Restorative, and Neurological Devices
Page 1 of _
510(k) Number_10 S