510(k) · Cleared
ClearedResponse BandLoc Spinal Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
OrthoPediatrics Corp. · OWI Bone Fixation Cerclage, Sublaminar
Cleared on Mar 16, 2020 as substantially equivalent to K161267 (OrthoPediatrics Corp., 2016) after a 60-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Mar 16, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K925812 (1993). 27 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- 6 generations backK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- 5 generations backK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- 4 generations backK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- 3 generations backK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- 2 generations backK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
- 1 generation backK161267 Response BandLoc Spinal FixationOrthoPediatrics Corp. · 2016 · Recalled
- This deviceK200097 Response BandLoc Spinal FixationOrthoPediatrics Corp. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| −6 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| −5 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| −4 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| −3 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| −2 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
| −1 | K161267 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2016 | 1 |
| 0 (this device) | K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 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 OWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K161267 | Response BandLoc Spinal FixationSummary page 4…21 CFR 888.3010 Legally marketed primary predicate device to which substantial equivalence is claimed: • Response BandLoc Spinal Fixation (K161267) Product Description The RESPONSE BandLoc Spinal Fixation implant consists of a titanium alloy tulip head clamp attached to a p… | 2016 |
| † | K181390 | Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System | 2018 |
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 27 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 27 ancestors have a recall of any class.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: • Spinal trauma surgery, used in sublaminar or facet wiring techniques; • Spinal reconstructive surgery, incorporated into constructs for the…
Read the full statement (137 words)
The RESPONSE BandLoc Spinal Fixation is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
• Spinal trauma surgery, used in sublaminar or facet wiring techniques;
• Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis;
• Spinal degenerative surgery, as an adjunct to spinal fusions;
• The RESPONSE BandLoc Spinal Fixation may also be used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200097 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200097: Response BandLoc Spinal Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200097
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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