510(k) · Cleared
ClearedPolaris BE Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Aug 6, 2007 as substantially equivalent to K940631 (Cross Medical Products, Inc., 1995) and 1 other predicate after an 81-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Aug 6, 2007
- Review
- 81 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901587 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −1 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| 0 (this device) | K071377 | Polaris BE Rods | Biomet Spine | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 1…Spinal Pedicle Fixation, for Degenerative Disc Disc Disease (NKB) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K940631 Synergy TM Spinal System (Interpore Cross, Inc.*) K950099 Synergy T M Ti Post… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…Disc Disease (NKB) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K940631 Synergy TM Spinal System (Interpore Cross, Inc.*) K950099 Synergy T M Ti Posterior Spinal System (Interpore Cross, Inc. *) Device Description: T… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 11 ancestors has a recall.
- 15 other devices also cite its predicate K940631.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures, They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion, The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods. As a…
Read the full statement (464 words)
The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures, They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion,
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system the SYNERGY Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to Si/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the SYNERGY Spinal System are:
1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10. Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the SYNERGY screws and lateral connectors are intended for sacral/iliac attachment only, and the SYNERGY hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071377: Polaris BE Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071377
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026