510(k) · Cleared
ClearedLateral Flare Internal Collar (Lfic)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pro-Lfic, LLC · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Dec 18, 1997 as substantially equivalent to K952776 (Zimmer, Inc., 1996) after a 209-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 18, 1997
- Review
- 209 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952776 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK952776 Lfic or Fetto HipZimmer, Inc. · 1996
- This deviceK971900 Lateral Flare Internal Collar (Lfic)Pro-Lfic, LLC · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952776 | Lfic or Fetto Hip | Zimmer, Inc. | 1996 | — |
| 0 (this device) | K971900 | Lateral Flare Internal Collar (Lfic) | Pro-Lfic, LLC | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWJ? 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? (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 |
|---|---|---|---|
| * | K952776 | Lfic or Fetto HipSummary page 5…with acute femoral neck fractures. The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc.,, P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for press- fit use into the intramedullary canal for pathological or degenerative conditions involving the femur… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, 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 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis…
Read the full statement (144 words)
The device is designed for press-fitting into the human femurs for total hip replacement. This hip is indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprosthesis and/or total hip components in the affected extremity; patients with acute femoral neck fractures.
The device is identical to the predicate hip of Zimmer LFIC Hip Prosthesis, Zimmer Inc.,, P.O. Box 708, Warsaw, Indiana 46581-0708, (K952776). It is intended for press-fit use into the intramedullary canal for pathological or degenerative conditions involving the femur and/or acetabulum. These stems are made of Tivanium Ti-6A1-4V Alloy and anatomic in shape.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971900: Lateral Flare Internal Collar (Lfic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971900
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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