(129 days)
Not Found
No
The summary describes a physical interbody fusion device and associated instrumentation, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is an intervertebral body fusion device used in the treatment of degenerative disc disease, which implies a therapeutic intent to alleviate symptoms and promote healing.
No
The device is described as an interbody fusion device, specifically spinal cages, used for spinal fusion procedures. Its purpose is to act as an implant for treatment, not to diagnose a condition. While it mentions "degeneration of the disc confirmed by history and radios" as a pre-requisite for its use, the device itself is not performing that diagnostic function.
No
The device description clearly states it is a physical implant (PEEK Cages with radio-dense markers) and associated instrumentation made of stainless steel and polymers. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes intervertebral body fusion devices (cages) and associated surgical instrumentation used for spinal fusion procedures. These are implants and surgical tools, not devices that perform tests on bodily samples.
- Intended Use: The intended use clearly states that the devices are for treating degenerative disc disease and are implanted surgically to facilitate spinal fusion. This is a therapeutic intervention, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples or providing diagnostic information. The imaging modalities mentioned (radios, radiographic studies, fluoroscopic) are used to guide placement and assess the outcome of the surgical procedure, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
LOSPA IS PLIF&ALIF Cage
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Patients should be skeletally mature and have had six months of non-operative treatment. Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS ACIF Cage
LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.
Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.
Product codes
MAX, ODP
Device Description
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices is available in various heights and Lordotic configurations with an open architecture to accept packing of bone graft material. The design features are common with the design features of all the predicate devices as described below,
- Straight and wedge / Lordotic designs to match vertebral anatomy ●
- Adequate interior graft space for optimal bony integration
- Superior and inferior ridges designed to prevent implant migration ●
- Similar structural characteristics, open architecture to accept packing of autograft ●
- . PEEK Cages (ASTM F2026) with radio-dense markers (Tantalum - ASTM F 560) for optimum fluoroscopic placement and post operative examination
- Available in multitude of similar sizes and lordotic ●
LOSPA IS PLIF Cage
- . Three versions are available according to the lordotic angles (0°, 4°, 8°)
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm) ●
LOSPA IS ALIF Cage
- Four versions are available according to the lordotic angles (6°, 8°, 12°, 15°) .
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm) .
LOSPA IS ACIF Cage
- Available in a convex version with 5° lordotic angle.
- It has various heights (5~12 mm), widths (12, 14 mm) and depths (14, 16 mm) .
LOSPA IS SPINAL SYSTEM INSTRUMENTATION
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices instrumentation consists of set of accessories to be used with LOSPA Cage implants. The instrumentation is classified as Class II. Class II instrumentations includes implant specific instrumentations. The instruments are designed similar to devices already in market and is simple, conventional, and accurate. The parts of the instruments are made of stainless steel and polymers which are biocompatible and used in medical industry for decades. The instrumentation is used for their respective procedures by qualified orthopedic surgeons.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies, fluoroscopic
Anatomical Site
lumbosacral region (L2-S1), cervical spine (C2-T1)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
qualified orthopedic surgeons, open, posterior or anterior approach
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)
Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ASTM F 2077 and ASTM F 2267. Mechanical testing of the subject device consisted of static axial compression, static compression shear, static torsion, dynamic axial compression, dynamic compression shear, dynamic torsion, subsidence and expulsion testing. The static and dynamic testing's, subsidence and expulsion results demonstrated that the subject device performed either similar or better than comparable predicate devices, there by establishing substantial equivalence for performance. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K073470, K103111, K122639, K042714, K120275, K083311
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are connected by a flowing, ribbon-like element. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the logo.
October 2, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Corentec Company, Limited J S Daniel Senior Manager/Engineer-RA/QA 8f Chungho Tower, 483, Gangnam-daero Seocho Gu, Seoul, 137-040 REPUBLIC OF KOREA
Re: K151408
Trade/Device Name: LOSPA IS Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 1, 2015 Received: September 2, 2015
Dear Mr. Daniel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151408
Page 1 of 1
Device Name LOSPA IS Spinal System
Indications for Use (Describe)
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Patients should be skeletally mature and have had six months of non-operative treatment.
Devices are intended to be implanted via an open, posterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in sketally mature patients with degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
Patients should have received at least six weeks of non-operative treatment with the device.
Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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3
K151408 Page 1 of 6
510(K) SUMMARY Corentec Co., Ltd. LOSPA IS Spinal System 31* Aug 2015
ADMINISTRATIVE INFORMATION
| Manufacturer | Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, 331-822 South Korea
Telephone: +82-41-585-7114
Fax: +82-41-585-7113 |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | J.S. Daniel
Senior Manager/Engineer – RA/QA
Corentec Co., Ltd
8F Chungho Tower, 483, Gangnam-daero,
Seocho Gu, Seoul, Korea 137-040
Ph: +82 70 4393 3819
Fax: +82 2 3445 5467
Email: isdaniel@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | LOSPA IS Spinal System |
|---|---|
| Common Name: | Intervertebral body fusion device |
| Classification Regulations: | 21 CFR 888.3080 |
| Regulatory Class: | II |
| Product Codes: | MAX, ODP |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
4
Page 2 of 6
INDICATIONS FOR USE
LOSPA IS PLIF&ALIF Cage
LOSPA IS PLIF&ALIF Cages are indicated for use with autogenous bone graft as intervertebral body fusion devices at one or two contiguous levels in the lumbosacral region (L2-S1) in the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Patients should be skeletally mature and have had six months of non-operative treatment. Devices are intended to be implanted via an open, posterior or anterior approach and used with autogenous bone and supplemental fixation.
LOSPA IS ACIF Cage
LOSPA IS ACIF Cage is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine.
Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.
Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation.
5
DEVICE DESCRIPTION
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices is available in various heights and Lordotic configurations with an open architecture to accept packing of bone graft material. The design features are common with the design features of all the predicate devices as described below,
- Straight and wedge / Lordotic designs to match vertebral anatomy ●
- Adequate interior graft space for optimal bony integration
- Superior and inferior ridges designed to prevent implant migration ●
- Similar structural characteristics, open architecture to accept packing of autograft ●
- . PEEK Cages (ASTM F2026) with radio-dense markers (Tantalum - ASTM F 560) for optimum fluoroscopic placement and post operative examination
- Available in multitude of similar sizes and lordotic ●
LOSPA IS PLIF Cage
- . Three versions are available according to the lordotic angles (0°, 4°, 8°)
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm) ●
LOSPA IS ALIF Cage
- Four versions are available according to the lordotic angles (6°, 8°, 12°, 15°) .
- It has various heights (8~16 mm) and lengths (22, 25, 28, 31, 34 mm) .
LOSPA IS ACIF Cage
- Available in a convex version with 5° lordotic angle.
- It has various heights (5~12 mm), widths (12, 14 mm) and depths (14, 16 mm) .
LOSPA IS SPINAL SYSTEM INSTRUMENTATION
The LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices instrumentation consists of set of accessories to be used with LOSPA Cage implants. The instrumentation is classified as Class II. Class II instrumentations
6
Page 4 of e
includes implant specific instrumentations. The instruments are designed similar to devices already in market and is simple, conventional, and accurate. The parts of the instruments are made of stainless steel and polymers which are biocompatible and used in medical industry for decades. The instrumentation is used for their respective procedures by qualified orthopedic surgeons.
SUBSTANTIAL EQUIVALENCE
The LOSPA IS Spinal System is similar to the 510(k) cleared devices as mentioned below with respect to indications, design, operating principles and material.
| 510(k) Number | Trade or Proprietary
or Model Name | Manufacturer | Predicate Type |
|---------------|---------------------------------------|---------------|----------------|
| K073470 | AVS PL Peek Spacer
(O.I.C) | Stryker | Primary |
| K103111 | FORZA Spacer | Orthofix Inc. | Additional |
| K122639 | SynCage Evolution | DepuySynthes | Additional |
| K042714 | Fidji | Zimmer | Additional |
| K120275 | ACIS | DePuySynthes | Additional |
| K083311 | CeSpace | Aesculap | Additional |
The LOSPA IS PLIF Cages have a tapered leading edge similar to the primary predicate device AVS PL Peek Spacer (O.I.C) [K073470] and additional predicate device, FORZA Spacer System [K103111], with central canal to receive bone graft and has either straight/wedged shaped designs or Lordotic designs to match the vertebral anatomy. The overall design and dimensional specification of LOSPA IS PLIF Cages is similar to its predicate devices.
The LOSPA IS ALIF Cages has a profile similar to additional predicate devices such as the SynCage Evolution [K122639] and Fidji [K042714], with central canal to receive bone graft and has either straight/wedged shaped designs or Lordotic designs to match the vertebral anatomy. The overall design and dimensional specification of LOSPA IS ALIF Cages is similar to its predicate devices.
The LOSPA IS ACIF Cages has a profile similar to additional predicate devices such as the ACIS [K120275] and CeSpace [K083311], with central canal to receive bone graff and has convex configuration with lordotic angle. The overall design and dimensional specification of LOSPA IS ACIF Cages is similar to its additional predicate devices.
7
Page 5 of 6
The design features of LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices are common with of all the predicate devices as described in device description.
At a high level, the LOSPA IS PLIF & ALIF and LOSPA IS ACIF Interbody Fusion Devices have the following similarities to the predicate devices:
- has the same intended use, ●
- has same indications for use,
- uses the same operating principles, ●
- incorporates the same basic designs & specifications, ●
- incorporates the same or similar materials, and
- is supplied Non Sterile and/or Sterile
PERFORMANCE DATA
Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ASTM F 2077 and ASTM F 2267. Mechanical testing of the subject device consisted of static axial compression, static compression shear, static torsion, dynamic axial compression, dynamic compression shear, dynamic torsion, subsidence and expulsion testing. The static and dynamic testing's, subsidence and expulsion results demonstrated that the subject device performed either similar or better than comparable predicate devices, there by establishing substantial equivalence for performance. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy.
STERILIZATION & PACKAGING
Similar to the predicate devices, the LOSPA IS Spinal Systems consisting of PLIF, ALIF & ACIF Interbody Fusion Devices are packaged in pouch and supplied sterile and non-sterile.
The non-sterile implants and all instruments used in the surgery must be sterilized by the end user, prior to use, as mentioned in the IFU. Steam sterilization validation for the subject non sterile devices was conducted as per, ISO 17665-1.
For the sterile components, following to gamma sterilization, packaging was subjected to sterile barrier testing to validate a shelf life of 5 years as per ISO & ASTM standards
8
Page 6 of 6
confirms the stability and effectiveness of packaging of the sterilized product during the shelf-life, by evaluating changes by accelerated aging, as per ASTM F1980. Gamma sterilization validation for the subject sterile devices was conducted as per, ISO 11137-1 & ISO 11137-2.
CONCLUSION
Overall, the LOSPA IS PLIF & ALIF Cages & LOSPA IS ACIF Cages are similar to the identified primary predicate device and additional predicates. Any differences in technological characteristic between the subject and primary predicate device and additional predicate do not raise new issues of safety or efficacy and has been adequately addressed in this premarket notification.