Reform® POCT System

K162300 · Precision Spine, Inc. · NKG · Nov 22, 2016 · Orthopedic

Device Facts

• Record ID: K162300
• Device Name: Reform® POCT System
• Applicant: Precision Spine, Inc.
• Product Code: NKG · Orthopedic
• Decision Date: Nov 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Device Story

Reform® POCT System is a posterior spinal fixation system for craniocervical, cervical, and thoracic (T1-T3) spine. System components include rods, occipital plates, occipital screws, cross-connectors, lateral connectors, domino connectors, and hooks. Components are implanted by surgeons in an OR setting to achieve spinal segment immobilization and stabilization. Implants are manufactured from medical grade titanium alloy or cobalt chromium alloy. System includes necessary instruments for inserting and securing implants. Components are supplied non-sterile and are single-use only.

Clinical Evidence

Bench testing only. Testing included static axial compression bending, static torsion, dynamic axial compression bending, static axial tension bending, and dynamic torsion performed in accordance with ASTM F1717-14 and ASTM F2706-08 (2014). Results confirm the device's mechanical strength is sufficient for its intended use.

Technological Characteristics

Materials: Medical grade titanium alloy or cobalt chromium alloy. Standards: ASTM F136, ASTM F138, or ISO 5832-3/5. Principle: Posterior spinal fixation/stabilization. Form factor: Rods, plates, screws, hooks, and connectors. Sterilization: Supplied non-sterile. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients with acute/chronic instabilities of craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3) requiring immobilization/stabilization as adjunct to fusion. Conditions include traumatic fractures/dislocations, instability/deformity, failed fusions, tumors, and degenerative disease (radiculopathy, myelopathy, discogenic pain, facet instability). Also indicated for spinal column integrity restoration in patients with advanced cervical tumors with limited life expectancy where fusion is not achievable.

Regulatory Classification

Identification

Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Special Controls

*Classification.* Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant. (3) Device components must be demonstrated to be biocompatible. (4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (5) Labeling must include the following: (i) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (ii) Intended use and indications for use including levels of fixation; (iii) Device specific warnings, precautions, and contraindications that include the following statements: (A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies ( *e.g.,* CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.” (iv) Identification of magnetic resonance (MR) compatibility status; (v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and; (vi) Detailed instructions of each surgical step, including device removal.

Predicate Devices

• VERTEX™ Reconstruction System (K152338)
• SureLOK (K150851)
• S4 Spinal System (K050979)
• VERTEX™ Reconstruction (K083071)

Submission Summary (Full Text)

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 22, 2016

Precision Spine, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K162300

Trade/Device Name: Reform® POCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: August 29, 2016 Received: August 30, 2016

Dear Mr. Maxwell:

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page. |

| 510(k) Number (if known) | K162300 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Reform® POCT System |
| Indications for Use (Describe) | The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. |

| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

Page 1 of 2

{3}------------------------------------------------

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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

732*M+UWOOCT[ "

| Uwdo kwgtøu'P co g< | Rt gekukqp'Ur kpg. "pe0" |
|------------------------------------|--------------------------------------------------|
| Uwdo kwgtøu'Cf ftguu< | 4272'Gz gewkxg'F tkxg" |
| | Rgctn'O U''5; 42: " |
| Uwdo kwgtøu"Vgrgr j qpg< | 823064206466" |
| EqpcevRgtuqp< | Mgppgyj 'E0O czy gmKK' |
| | Go rktkecr'Vguvkpi 'Eqtr 0' |
| | 93; 04; 308: 96" |
| F cvg'Uwo o ct { 'y cu'Rtgr ctgf < | 39'P qxgo dgt"4238" |
| Vtcfg"qt'Rtqr tkg\ct{'P co g< | Tghqto Ì 'RQEV''U{uvgo " |
| Eqo o qp"qt"Wuwcn'P co g< | Qt vj quku. 'Egtxlecn'Ur kpcriRgf keng'Hkzcvkqp" |
| | Crrrkcpeg. "Hzcvkqp. "Ur kpcriovgtrico kpen" |
| Ercuukhkeckqp< | Wpercuulkkgf |
| Rtqf wevEqf g< | PMI. "MY R" |
| Ercuukhkeckan "Repon" | F kxkukun"qh'Otyi qr gf ke"F gxlegu" |

### F GUET RVKQP QH'VJ G'F GXIEG'UMDLGE V'VQ'RTGO CTMGVP QVHIRC VKP <

Vj g"Tghto Ì "RQEV" U{urgo "kl"c"r qurgtlyt"ur local'Hzcvkap" u{ uspo "ky gp" gf" i'r t" liwukup" all" ij g" Qeekr kcn" Egtxlecn" cpf "Vj qtcele" tgj lgpu" qh' vj g" ur kpg" "Qeelr w/ V5 #0 Vi g" ukugo "eqpularu" qh" c" xctlgv{ "qlitqf u."qeek" kcn"r roygu "qeek" kcdlxtgy u."etquveqppgevqtu."revgtcdighugy." f qo lpq"eqpgevqtu." cpf "j qqm" xq" cej lgxg" cp" ko r repv" equgn(" o crej gu" c skgpv" cpcwo {0'Vj g"Tghto "RQEV"U{urgo "lo r repu"ctg"|ttqo "vkcpkwo "cmq{."qt" eqdcn"ej tqo kwo "cmq{u"cu"f guetklgf "d{"incpf ctf u"uwej "cu"CUVO "H358."CUVO "H3759."qt"KUQ" 7: 54/50% r r p w ''o cf g'lt qo "o gf lecn'i tcf g'' kcpkwo .''o gf lecn'i tcf g'' lecn' i tcf g"eqdcm"ej tqo kwo "o c{"dg"wgf "iqi gy gt."j qy gxgt."uj qwf "pqv"dg"wugf"y kj "uckprgul"uggdl" Vj g'u{ugo "cnq"}penw gu'y g"lput wo gpw"pgeguct { "htt"|yugtskpi "cpf "ugewtkpi "yj g"lo r repul"Vj g" eqo r qpgpw"ctg"uwr r rlgf "ergcp"cpf "õP QP /UVGT KNGö0Cmllo r repu"ctg"ulpi ng"wug"qpn{"cpf "bj_qwft" pqv'dg'tgwugf "wpf gt"cp { "eltewo uxcpegu0"

#### KF F IEC VRP UHQT "M G"

Vj g" Rtgektkgp" Urløg" Tgfato Ì " RQEV" U{ugo " ki" kpypf gf " vq" r tqxkf g" lo o qdktk cvap" cpf " uncdkt cwqp" qh" ar loch" ago o gpw" cu" cf lwpev" xq" vj g" hymy lpi " cewg" cpf " ej tqple" kpuvcdkkgu"qh"yj g"etcplqegtxlecn"|wpevgp."yjg"egtx|ecn"urlpg":"E3""|| g"'| qtcele":ur lpg" It qo "V3/V5 " t c w c we" ur lpcn" int" to wo cve" f knnee vapu " knnedkky" at "f ghat o ksj = hekgf" r tgxlqwu" hwlqpu" *gd 0" r ugw cty tquld=" wo qtu" kpxqxkon" ur log=" cpt" f gi gpgtckxg"flugcug.llpent kpi "kptcevcdrg"tcf kewar cyj {"opf lqt"o {gmr cy { ."pgemcpf lqt"cto "rchp" qh" keqi gple "qtk lp"cu"eqplato gf "d/ "tcf kqi tcr j le"uwf lgu"cyf "f gi gpgtcvkxg"f kgg"rcegu" y kij "kpuvcdkkd (V Vj g"Rtgelukqp" Ur kpg"Tghto I "RQE V" Uj ungo "ku" cruq" ky g" y g" y g" t gungt g" y g" longi tkv "ql"yj g"ur lpcri'eq1wo p"gxgp"lp"yj g"cdugpeg"qh"1."ho kgf "vlo g"r gtlgf" "lg"r cvlgpw"

{5}------------------------------------------------

with advanced stage turnors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The indications for use for the Reform® POCT System is similar to that of the predicate devices listed in Table 5-1.

| 510k<br>Number | Trade or Proprietary<br>or Model Name | Manufacturer | Type |
|----------------|---------------------------------------|-----------------|------------|
| K152338 | VERTEX™<br>Reconstruction System | Medtronic | Primary |
| K150851 | SureLOK | Precision | Additional |
| K050979 | S4 Spinal System | Aesculap®, Inc. | Additional |
| K083071 | VERTEX™<br>Reconstruction | Medtronic | Additional |

Table 5-1 · Predicate Devices

## TECHNOLOGICAL CHARACTERISTICS

The following technological characteristics are similar between the subject and predicate devices:

- Principles of operation
- Materials
- . Sterility

### PERFORMANCE DATA

The Reform® POCT System has been tested in the following test modes:

- Static axial compression bending per ASTM F1717-14 .
- Static torsion per ASTM F1717-14 .
- Dynamic axial compression bending per ASTM F1717-14 .
- Static axial compression bending per ASTM F2706-08 (2014) ●
- Static axial tension bending per ASTM F2706-08 (2014) .
- Static torsion per ASTM F2706-08 (2014) ●
- Dynamic axial compression bending per ASTM F2706-08 (2014) ●
- Dynamic torsion per ASTM F2706-08 (2014) ●

The results of this non-clinical testing show that the strength of the Reform® POCT System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

# CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Reform® POCT System is substantially equivalent to the predicate device.