510(k) · Cleared
ClearedSynergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cross Medical Products, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Mar 5, 1998 as substantially equivalent to K934429 (Buckman Co., Inc., 1994) and 3 other predicates after a 148-day review. Its family tree reaches back 2 generations to 1990. 529 later devices descend from it.
- Decided
- Mar 5, 1998
- Review
- 148 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K901587 (1990). 13 ancestors in all. 529 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 1 generation backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- This deviceK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- Descendant · cites it directly · 311 of its ownK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- Descendant · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
- Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · 2 generations on · 176 of its ownK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
Showing 5 of 529 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 529 · See all- K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…Cross Medical Products, Inc. · 1998 · cites it directly311descendants
- K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · cites it directly251descendants
- K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
- K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
- K993503Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000 · 2 generations on176descendants
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) | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| +1 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| +1 | K982914 | Aesculap Spine System Evolution: Additional Components | Aesculap, Inc. | 1998 | — |
| +1 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| +2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +2 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 12 | 0 |
| 2012 | 17 | 0 |
| 2013 | 17 | 0 |
| 2014 | 20 | 0 |
| 2015 | 21 | 0 |
| 2016 | 25 | 0 |
| 2017 | 29 | 0 |
| 2018 | 28 | 0 |
| 2019 | 24 | 0 |
| 2020 | 38 | 0 |
| 2021 | 30 | 0 |
| 2022 | 34 | 0 |
| 2023 | 44 | 0 |
| 2024 | 45 | 0 |
| 2025 | 48 | 0 |
| 2026 | 44 | 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 MNH? 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? (4)
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 2…-house SOP’s and/or ASTM Standards are utilized as appropriate. K173936 (p 245 Substantially Equivalent Device(s): 1. SYNERGY™ Anterior Spinal System: K934429, K950709 2. SYNERGY™ Posterior Spinal System: K940631, K950099 Device Description: Background: This document summarizes safety… | 1994 |
| * | K950709 | Synergy TI Anterior Spinal SystemSummary page 2…P’s and/or ASTM Standards are utilized as appropriate. K173936 (p 245 Substantially Equivalent Device(s): 1. SYNERGY™ Anterior Spinal System: K934429, K950709 2. SYNERGY™ Posterior Spinal System: K940631, K950099 Device Description: Background: This document summarizes safety and effe… | 1995 |
| * | K940631 | Cross Medical - Synergy (TM) Spine SystemSummary page 2…ropriate. K173936 (p 245 Substantially Equivalent Device(s): 1. SYNERGY™ Anterior Spinal System: K934429, K950709 2. SYNERGY™ Posterior Spinal System: K940631, K950099 Device Description: Background: This document summarizes safety and effectiveness information for the SYNERGY™ Spinal… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 2…K173936 (p 245 Substantially Equivalent Device(s): 1. SYNERGY™ Anterior Spinal System: K934429, K950709 2. SYNERGY™ Posterior Spinal System: K940631, K950099 Device Description: Background: This document summarizes safety and effectiveness information for the SYNERGY™ Spinal System-Ad… | 1997 |
What descends from it? (529)
See all 5298 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior… | 1998 | 311 |
| K982914 | Aesculap Spine System Evolution: Additional Components | 1998 | 251 |
| K980484 | Aesculap Spine System Evolution | 1998 | 251 |
| K072022 | Valeo Pedicle Screw Spinal System | 2007 | 100 |
| K112684 | Mont Blanc Pedicle Screw Systems | 2012 | 5 |
| K080241 | DDS Stabilization System | 2008 | 5 |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | 2017 | 2 |
| K181995 | Chiral Surgical Pedicle Screw System | 2018 | 0 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K974749 (Cross Medical Products, Inc., 1998) has gone furthest, with 311 descendants of its own.
- 3 other devices also cite its predicate K934429.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
As a pedicle screw system, it 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 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 S1/Ilium. As a…
Read the full statement (207 words)
As a pedicle screw system, it 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 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 S1/Ilium.
As a posterior, non-pedicle screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications 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 levels of use are T1 to the Sacrum/Ilium. For anterior use, the levels of use are T10 to L3 for the double rod constructs, and T5 to L5 for the single rod constructs.
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/K973836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973836: Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross Medical-Synergy Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973836
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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