(79 days)
Not Found
No
The summary describes a traditional hip implant system and its materials, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is described as an artificial hip joint intended to replace a hip joint and alleviate severe hip pain and disability due to various conditions, which are characteristics of a therapeutic device.
No
The device is an Excia Hip System, which is an orthopedic implant intended to replace a hip joint. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a hip implant system made of materials like CoCrMo and Ti, intended for surgical implantation to replace a hip joint. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to replace a hip joint. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a femoral stem, a component of a hip implant. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition. The device itself is the treatment.
IVD devices are used to perform tests on samples to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to treat a physical condition by replacing a damaged joint.
N/A
Intended Use / Indications for Use
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- Patients suffering from disability due previous fusion ●
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCrMo and is intended for cemented fixation. The other femoral stem is for uncemented fixation and manufactured from Ti with Plasmapore with or Without µ CaP®.
Product codes
LWJ, JDI, MEH, LZO
Device Description
The Excia lateral offset femoral stem is available in two designs and standard lengths. The stem is designed to provide an increased offset during total joint replacement. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use.
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)
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement",
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings . on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements",
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" . Modular Implant Components",
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", ◆
- "Points to Consider for Femoral Stem Prostheses", .
- "Guidance Document for the Preparation of Premarket Notifications for . Ceramic Ball Hip Systems and
- . "Data Requirements for Ultrahigh Molecular Weight Poletheylene (UHMWPE) Used in Orthopedic Devices" was completed where applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042344, K060437, K040191, K991123, K972641
Reference Device(s)
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
§ 888.3350 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
Excia Total Hip System Lateral Offset
SPECIAL 510(k) Premarket Notification
| K061344 (pg 1 of 2)
Page 1 of 2
| B. 510(k) SUMMARY (as required by 21 CFR 807.92) | AUG 02 2006 | |
|---|---|---|
| Excia Total Hip System | ||
| (Excia Lateral Offset) | ||
| May 12, 2006 | ||
| COMPANY: | Aesculap®, Inc. | |
| 3773 Corporate Parkway | ||
| Center Valley, PA 18034 | ||
| Establishment Registration Number: 2916714 | ||
| CONTACT: | Kathy A. Racosky | |
| 800-258-1946 (phone) | ||
| 610-791-6882 (fax) | ||
| kathy.racosky@aesculap.com (email) | ||
| TRADE NAME: | Excia Total Hip System Lateral Offset | |
| COMMON NAME: | Femoral Hip Stem | |
| CLASSIFICATION NAME: | Prosthesis, hip, semi-constrained, metal/polymer, | |
| uncemented | ||
| Prosthesis, hip, semi-constrained, metal/polymer, | ||
| cemented | ||
| Prosthesis, Hip, semi-constrained, uncemented, | ||
| metal/polymer, non-porous, calcium-phosphate | ||
| Prosthesis, Hip, Semi-Constrained, | ||
| Metal/Ceramic/Polymer, Cemented or Non-Porous, | ||
| Uncemented |
REGULATION NUMBER: 888.3360, 888.3350, 888.3353, 888.3353
LWJ, JDI, MEH, LZO PRODUCT CODE:
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Lateral Offset Femoral Stem is a line extension of Aesculap's Excia Total Hip System that was cleared (K042344). It is also substantially equivalent to the Excia Total Hip System with u-CaP® (K060437), BiContact Hip System (K040191), PERFECTA RS Lateralized Hip Stem (K991123) and Dual Offset PERFECTA IMC Hip Stem (K972641):
DEVICE DESCRIPTION
The Excia lateral offset femoral stem is available in two designs and standard lengths. The stem is designed to provide an increased offset during total joint replacement. One is manufactured from Ti with a plasma spray coating (Plasmapore) with or with out u-CaP®. This component is intended for uncemented use. The other femoral component is manufactured from CoCrMo and is intended for cemented use.
1