510(k) · Cleared
ClearedSynergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 13, 2001 as substantially equivalent to K934429 (Buckman Co., Inc., 1994) and 1 other predicate after a 17-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Sep 13, 2001
- Review
- 17 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934429 (1994). 2 ancestors in all. 11 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK934429 Anterior Spine SystemBuckman Co., Inc. · 1994
- This deviceK012871 Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196…Interpore Cross Intl. · 2001
- Descendant · cites it directly · 6 of its ownK042143 Excella-M Spinal SystemInnovasis, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK071921 Innovasis Excella Spinal System, Excella-M (Monoaxial Screws)…Innovasis, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK102248 Excella II Spinal System Model EC2-00Innovasis, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK140238 Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK241276 Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K042143Excella-M Spinal SystemInnovasis, Inc. · 2004 · cites it directly6descendants
- K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc. · 2007 · 2 generations on5descendants
- K102248Excella II Spinal System Model EC2-00Innovasis, Inc. · 2010 · 3 generations on4descendants
- K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc. · 2014 · 2 generations on3descendants
- K241276Vector™ Pedicle Screw SystemInnovasis, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934429 | Anterior Spine System | Buckman Co., Inc. | 1994 | — |
| 0 (this device) | K012871 | Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174… | Interpore Cross Intl. | 2001 | — |
| +1 | K042143 | Excella-M Spinal System | Innovasis, Inc. | 2004 | — |
| +2 | K071921 | Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P… | Innovasis, Inc. | 2007 | — |
| +3 | K102248 | Excella II Spinal System Model EC2-00 | Innovasis, Inc. | 2010 | 3 |
| +2 | K140238 | Excella Iii-D Spinal Deformity System | Innovasis, Inc. | 2014 | 2 |
| +3 | K241276 | Vector™ Pedicle Screw System | Innovasis, Inc. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K934429 | Anterior Spine SystemSummary page 1…DEVICE The predicate device is the INTERPORE CROSS International Synergy Integral Open Screw for anterior and posterior use, which was previously cleared under 510(k)’s K934429 and K940631. INDICATIONS-FOR-USE The Synergy Spinal System implants are intended to be used as a temporary construct that assis… | 1994 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 1…redicate device is the INTERPORE CROSS International Synergy Integral Open Screw for anterior and posterior use, which was previously cleared under 510(k)’s K934429 and K940631. INDICATIONS-FOR-USE The Synergy Spinal System implants are intended to be used as a temporary construct that assists normal he… | 1995 |
What descends from it? (11)
See all 114 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 (449 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-S1) vertebral joint; (b) who are having the screws fixed or attached to the lumbar and sacral spine; (c) who are receiving fusions using autogenous bone graft only; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/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 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 — L3 for the double rod constructs and T5 — L5 for the single rod construct. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35mm 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012871: Synergy TI Integral Open Screws Models # 6193, 6194, 6195,6196, 6173, 6174, 6175, 6176, 6177.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012871
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026